958 Regulatory Affairs jobs in the United States

We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dynamic company, we encourage you to apply.

Responsibilities:

• Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory authorities.
• Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry.
• Assist in the preparation of regulatory submissions including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments.
• Coordinate with cross-functional teams to gather necessary information for regulatory submissions.
• Ensure timely and accurate communication with regulatory authorities.
• Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies.
• Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management.
• Maintain accurate and organized regulatory files and records.

Requirements:

• Bachelor's degree in a related field such as biology, chemistry, or pharmaceutical sciences.
• Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.
• Strong understanding of FDA regulations and guidelines.
• Excellent organizational and time management skills.
• Strong attention to detail and ability to handle multiple projects simultaneously.
• Effective communication skills, both written and verbal.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a team.

Role Regulatory Affairs Specialist
Location: Westlake, OH
Duration: 9 months ( Temp to hire)
Pay Rate: $24 .00 /hr. W2 (Without any benefits)

Job Title : Regulatory Affairs Specialist

JOB DESCRIPTION

Qualifications:
Bachelor's degree in chemistry, Biology, Toxicology, or related field. Experience in professional level position in business. Experience with OSHA/TSCA/RCRA/Export regulations desirable. Ability to manage multiple projects while effectively communicating status to senior staff. Excellent written and oral communication skills. Excellent Computer Skills. SAP experience, preferred

Background in Industrial Chemical Regulatory Affairs, preferred.
Responsibilities:
•Responsible for classifying new and existing products according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). This will require understanding of local country adoption of such as US (Haz Comm 2012) and Canada (WHMIS 2015).
•Pre-Authoring of Safety Data Sheets (SDS) and labels in accordance with Haz Comm 2012 and WHMIS 2015.
•Supporting projects related to management of change and the regulatory process.
•Answering Simple Customer Queries

Job Description

Regulatory Affairs Assistant
Pittsburgh, PA - Robinson Township

Pay $23/hr

Johnson Service Group (JSG) is currently looking for a Regulatory Affairs Assistant with a chemistry or chemistry-related degree. This is a long-term contract hire opportunity with a global specialist chemicals company located in Pittsburgh PA. This position is required onsite.

Skills/Experience:

• A minimum of a Bachelor's degree in chemistry, biology or related science field

Required Skills:

• Strong computer skills - advanced knowledge of Microsoft Office, other databases and the ability to learn new databases quickly
• Must be able to handle multiple projects/priorities with deadlines at a time
• Must work well in a team setting, be willing to reach out to other team members with questions and communicate well

Desired Skills:

• At least 1-3 Years of experience in a Product Safety and/or Regulatory Affairs role preferred.
• EHS or Product Safety experience is a plus with familiarity with EHS regulations such as GHS, DG Classification and TSCA, and Safety Data Sheet (SDS) familiarity and/or authoring experience a big plus

Degree Requirements:

• A minimum of a Bachelor's degree in chemistry, biology or related science field. Must have taken 2 years of Chemistry courses if degree is in related field.

Job Description:
We like to stress that is in a full-time computer office position. We get a lot of applicants coming from the lab setting, and this job is completely different. We want applicants to be aware that although we are a chemical company, this is a Product Safety & Regulatory affairs position. Some people do transition from the lab well.

• Responsible for assisting with ensuring compliance with US OSHA and Canadian Workplace Hazardous Materials Information System (WHMIS). This includes gathering, maintaining and correcting data in to the SAP EHS database for the preparation of Safety Data Sheets (SDSs), preparation of data for regulatory reports, and responding to customer requests for information regarding regulatory compliance and products.

Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies.
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

#D400
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Job Description

Description / Summary:
We are seeking a highly skilled and experienced Regulatory Affairs Operations Specialist to join our Regulatory Affairs Operations team. The position will be responsible for designing, developing, and implementing international addendum labeling (IFUs, import labels, country-specific labeling) that meets international requirements for our medical devices. This role requires background in regulatory affairs and experience with labeling from a regulatory perspective. The individual will be responsible for liaising with international RA local experts and US RA product owners as key stakeholders.

Key Responsibilities:
This role will introduce a new process to centralize post-approval addendum labeling activities for the companies Vascular medical device portfolio.

Initiatives include but are not limited to:

Label Design and Development:
• Collaborate with Regulatory Affairs specialists, international regulatory affiliates, and labeling project management to develop labeling strategies.
• Create and design addendum labeling including Instructions for Use (IFUs), product labels, import labels, and country-specific labeling.
• Fulfill international addendum labeling requests, ensuring conformance with international country requirements, country of origin, and international certification marks.
• Ensure all labeling complies with regulatory requirements and standards.
• Effectively work with cross-functional team to develop labeling that meets the requirements of the FDA and international regulatory agencies, internal brand/design requirements, and product specifications.
• Independently manage large-scale labeling change projects.
• Communicate labeling projects and priorities across the division, plan project timelines which may involve managing multiple, concurrent deadlines.
• Complete assessments for projects to identify scope and impact to labeling.
• Understand impact of changing regulations and product requirements regarding labeling.

Labeling Implementation:
• Fill out forms, coordinate redlines review and submit labeling packages to the labeling team for development.
• Coordinate labeling release with Regulatory Affairs specialists, international regulatory affiliates, and the Packaging, Labeling, and Program Management (PLPM) team.
• Prepare and submit Universal Addendum Labeling (UAL) SAP package to PLPM team to program addendum labeling.
• Troubleshoot issues, communicate impact, and propose solutions.

Regulatory Affairs / Regulatory Intelligence:
• Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
• Ensure all labeling activities comply with internal procedures and regulatory requirements.
• Stay updated on changes in regulatory requirements and implement necessary updates to internal procedures.
• Driving quality system process improvement initiatives (e.g. change management).
Documentation and Reporting:
• Maintain accurate records of labeling changes and approvals.
• Track labeling change requests for multiple projects.
• Provide documentation and support for audits.
• Driving preparation of KPI dashboards and maintaining a pulse on formal RA internal metrics.

Qualifications:
• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum 4 years of experience in a regulated industry and experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering and/or regulatory.
• Experience working with policies and procedures impacting documentation and documentation practices.
• Proven experience in labeling design and development from a regulatory perspective.
• Strong knowledge of regulatory requirements for medical device labeling.
• Proficiency in SAP MD and other relevant software systems.
• Excellent communication and collaboration skills.
• Detail-oriented with strong organizational skills.
• Good people relations, able to work independently with good administrative and time management skills. PC and Microsoft Office experience.

Preferred Qualifications:
• Experience with medical device labeling or labeling for highly regulated industry and international regulatory requirements.
• Familiarity with Adobe Acrobat Pro, SAP, and other content management systems.
• Substantial experience coordinating and executing project activities in a highly regulated industry.

Skills:
• Independent
• Troubleshooting
• Critical thinker
• Ability to drive a problem through resolution and implement mitigations
• Ability to handle multiple streams simultaneously

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

Pay ranges between $38-42.30/hr based on expereince

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

Responsibilities:

• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Responsible for managing and compiling CMC sections of marketed product variations.
• Partner with RA CMC Project Leads and develop module 3 content and project timelines.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Skills for running review meetings for submission documents.
• Understand CMC expectations including CTD content, structural and formatting requirements.
• Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Independently facilitate project team meetings.
• Superior oral and written communication skills
• Ability to work cooperatively with all levels and types of global personnel required
• Experience working with electronic document management systems
• Ability to work independently. Manage multiple projects simultaneously.
• Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
• Detail/accuracy oriented, collaborative and willing to learn
• Familiarity with US and other international regulatory requirements for dossiers.

Requirements:

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline.
• 4 years pharmaceutical. 1-2 years cross functional project management.
• 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3).
• May require an advanced degree and 3 to 5 years of direct experience in the field.
• Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
• Relies on extensive experience and judgment to plan and accomplish goals.
• Performs a variety of tasks.