4 Regulatory Affairs Specialist jobs in Puerto Rico

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objectives:**
Lead and execute global regulatory strategies for development programs and marketed products across CMC and clinical/non-clinical, labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.
**Responsibilities:**
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains.
+ Provide technical expertise and regulatory direction to project teams throughout the product lifecycle.
+ Proactively communicate strategy, risks, and critical issues to stakeholders and senior leadership.
+ Influence internal and external stakeholders, including Key Opinion Leaders (KOLs), to achieve strategic objectives.
+ Serve as primary regulatory point of contact with Health Authorities and manage ongoing relationships.
+ Participate in assigned due diligence activities for business development and acquisitions.
+ Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions.
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDAs and amendments/supplements.
+ Serve as RA representative on facility/site Local Change Management Boards.
+ Ensure operational excellence, compliance, and timely execution of deliverables.
+ Drive regulatory strategies for clinical, non-clinical, CMC and labeling development plans, ensuring alignment with global requirements.
+ Provide guidance on risk assessment, clinical trial design implications, and regulatory pathways.
+ Support interactions with Health Authorities for development programs.
+ Ensure high-quality submissions by proofreading and checking documents for accuracy and consistency.
+ Contribute to continuous learning, process improvement, and knowledge-sharing initiatives.
+ Mentor and coach team members in regulatory strategy and submission excellence.
+ Monitor and report on performance metrics to drive operational effectiveness.
+ Participate in external forums, regulatory boards, and committees to influence regulatory policies and industry standards.
**Qualifications:**
+ Bachelor degree or equivalent, Master degree preferred
+ Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them as appropriate
+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
+ Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
+ Strong interpersonal skills with the ability to influence others in a positive and effective manner
+ Demonstrated ability to contribute to a continuous learning and process improvement environment
+ Excellent communication skills; both oral and written
+ Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work with key national opinion leaders, and advisory boards
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s): ((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $120,000 to $180,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please readBausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs: Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

As we create a colorful, capable and cleaner world through chemistry, we invite you to join our team to harness the power of chemistry to shape markets, redefine industries and improve lives for billions of people around the world.
**CREATING ESSENTIAL CHEMISTRY THE WORLD NEEDS **
At Chemours, our people are redefining how the world thinks of chemistry by approaching everything we do with a commitment to delivering Trusted Chemistry that creates better lives and helps communities thrive.   That begins with how we use our science, data, and unmatched technical expertise to develop market-leading products with the highest levels of performance, sustainability, and safety in the industry. 
Powered by chemistry, our products are used in applications that make the products we rely on, processes, and new technologies possible.  In key sectors such as clean energy, advanced electronics, high-performance computing and AI, climate friendly cooling, and high-quality paints and coatings for homes and industrial infrastructure---sustainable solutions and more modern living depend on Chemours chemistry. 
Chemours is seeking a **Director of Regulatory Advocacy** to join our growing Government Affairs team! This position will report directly to the Vice President - Government Affairs at our **Washington, DC office** .
The successful candidate will join Chemours' Global Government Affairs Group with a primary responsibility for supporting U.S. federal regulatory affairs engagement with the United States Environmental Protection Agency (USEPA), as well as other select federal administrative agencies; key trade organizations that help shape regulatory policies at the U.S. federal level; and members of the U.S. Congress and their staffs. In addition, this strategic and high-profile role will be part of the Thermal & Specialized Solutions (TSS) leadership team, focusing on advocacy of our current and future TSS product portfolio.
The responsibilities of the position include, but are not limited to, the following:
+ Demonstrate a high degree of knowledge about the political, economic, and social factors affecting public policy decision making; how engagement with government officials can lead to the enactment of new or the modification of existing regulations; implement policies and take other governmental actions that are favorable to Chemours' business growth, corporate well-being, and the industry sectors in which the company operates.
+ Establish and lead a high-performing team of advocacy professionals, including setting strategic objectives for the team and individuals, talent development, and succession planning.
+ Develop and maintain relationships with key federal officials, particularly the USEPA and other leaders in the executive branch, to establish Chemours as a trusted source of knowledge and perspective as regulatory decisions are considered and made.
+ Serve on the TSS Business leadership Team and promote collaboration and professional exchange across the organization.
+ Monitor and analyze U.S. federal and select international regulation relevant to Chemours.
+ Develop and implement strategies and tactics for outreach, advocacy and market positioning aimed at achieving competitive advantage and the most beneficial solutions for Chemours or minimizing potential negative impacts of regulatory decisions.
+ Participate in the development of Chemours' public policy agenda and positions with a specific focus on issues to be decided by environmental regulatory agencies.
+ Interface regularly with Chemours' senior management and business leaders on U.S. federal and select international regulatory issues.
+ Provide thought leadership and counsel on select international (e.g., Canada and Latin America) environmental regulatory issues; supporting trade association work; and leading regulatory engagement on key matters in these jurisdictions.
+ Liaise with the Chemours' businesses, as well as corporate functions such as Legal, Corporate Remediation, Environmental Center of Excellence, Corporate Sustainability, Corporate Product Regulatory Compliance, Corporate Toxicology and Risk Assessment, Finance, and Communications, among others, to ensure coordination and integration of the company's public policy agenda.
+ Support Chemours' evaluation and engagement in industry coalitions that operate at the federal level and international levels to engage on regulatory processes and decisions.
+ Facilitate interactions by Chemours' business and functional representatives with key government officials, including agency and legislative leaders, to advocate the company's position on pending regulatory proposals and existing regulations.
+ Lead both in the macro (developing policy positions) and the micro (developing and executing advocacy campaigns) to create success for Chemours via effective regulatory engagement.
The following is _required_ for this role:
+ Bachelor's degree and previous regulatory affairs experience, including direct advocacy with USEPA and other federal executive branch agencies and offices, (10+ years).
+ Knowledge of the political, economic, and social environment in the United States at the federal level, and internationally with a focus on Canada and Latin America.
+ Ability to positively represent the company's views and positions with external audiences, especially regulators and administrative agency policy makers.
+ Ability and willingness to lead and manage complex subject matters/issues, often engaging collaboratively within cross-functional and cross-business teams and with subject matter experts.
+ Excellent project planning, management, and communication skills with demonstrated ability to deal effectively with diverse groups of people and their perspectives.
+ Experience leading teams through change with clarity and confidence, proactively anticipating and addressing concerns and modeling ethical behavior
+ Live or be willing to relocate to the Washington, D.C. area.
+ Willingness and ability to travel up to 15 percent of total work time.
**Benefits:**
Competitive Compensation
Comprehensive Benefits Packages
401(k) Match
Employee Stock Purchase Program
Tuition Reimbursement
Commuter Benefits
Learning and Development Opportunities
Strong Inclusion and Diversity Initiatives
Company-paid Volunteer Days
We're a different kind of chemistry company because we see our people as our biggest assets. Instead of focusing just on what our employees do each day, we look at how they do it-by taking a different approach to talent development, employee engagement, and culture. Our goal is to empower employees to be their best selves, at Chemours and in life.
Learn more about Chemours and our culture by visiting Chemours.com/careers. ( is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, religion, color, gender, disability, national or ethnic origin, ancestry, marital status, family status, sexual orientation, gender identity or expression, or veteran status. Jurisdictions may have additional grounds for non-discrimination, and we comply with all applicable laws._
_Chemours is an E-Verify employer_
_Candidates must be able to perform all duties listed with or without accommodation_
_Immigration sponsorship (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status) is not currently available for this position_
_Don't meet every single requirement? At Chemours we are dedicated to building a diverse, inclusive, and authentic workplace for our employees. So if you're excited about this role, but your past experience doesn't align perfectly with every qualification in the position description, we encourage you to apply anyways. You may just be the right candidate for this or other opportunities_
_In our pursuit to be the greatest place to work, we know that a critical element to enhancing our employee experience is to assure we're operating with a solid foundation of trust. At Chemours, this means being transparent about how we pay our employees for the work that they do._
Pay Range (in local currency):
$169,344.00 - $264,600.00
Chemours Level:
30
Annual Bonus Target:
27%
Annual Stock Amount
65,000.00 USD
_The pay range and incentives listed above is a general guideline based on the primary location of this job only and not a guarantee of total compensation._ _Factors considered_ _in extending a compensation offer include (but are_ _not limited to)_ _responsibilities of the_ _job, experience,_ _knowledge, skills, and abilities, as well as internal equity, and alignment with market data. The incentive pay is dependent on business results and individual performance and subject to the terms and conditions of the specific plans._
At Chemours, you will find sustainability in our vision, our business and your future. If you want to work on the leading edge of your field and have a desire to make a difference, join Chemours and discover what it means when we say "We Are Living Chemistry."
Every day Chemours delivers Trusted Chemistry that enables products and technologies that people rely on to live better and thrive. A global leader in industrial and specialty chemicals, our chemistry enables vital innovations from high-performance computing, artificial intelligence (AI), and advanced electronics to batteries for electric and low-emissions vehicles, climate friendly cooling, paints and durable coatings for advanced infrastructure, and more.
Through our three businesses - Thermal & Specialized Solutions, Titanium Technologies, and Advanced Performance Materials - we deliver chemistry-based innovations that solve our customers' biggest challenges.
**PLEASE USE A WEB BROWSER OTHER THAN INTERNET EXPLORER IF YOU ENCOUNTER ISSUES (CHROME, FIREFOX, SAFARI, ETC.)**

**Position Summary**
Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
**J** **ob Responsibilities**
- Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
- Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.
- Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.
- Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
- Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.
- Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
- Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.
- Serves as the sponsor point of contact to the health authority.
- Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.
- Effectively manages and directs internal support staff and external consultants for assigned projects.
- Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.
- Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.
- Assess and develop innovative ideas to move GRA department to address current and future challenges.
**K** **nowledge, Skills, and Competencies**
**K** **nowledge**
- Experience working in the pharmaceutical and/or healthcare industry.
- Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
- RAC certification a plus.
**Skills**
- Strong oral and written communication skills.
- Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.
- Able to successfully interpret and apply regulatory intelligence to work output.
- Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
- Able to establish close communications and working relationship with cross functional teams to meet business objectives.
Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).
**Competencies**
See OPDC Competencies Chart (Level X)
**P** **hysical Demands and Work Environment**
Travel (approximately 20%)
See document Physical Demands and Work environment for further requirements.
**Education and Related Experience**
Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.