923 Financial Regulations 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.

• 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.

We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to manage regulatory submissions, ensure product compliance with global regulations, and support product development teams throughout the approval process. The ideal candidate will be well-versed in FDA, EMA, and/or international regulatory guidelines.

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Key Responsibilities:
• Prepare, compile, and submit regulatory documents to health authorities (e.g., FDA, EMA, etc.)
• Maintain up-to-date knowledge of applicable regulations and standards (e.g., ISO, ICH, GxP)
• Communicate regulatory requirements to cross-functional teams including R&D, QA, and manufacturing
• Ensure timely and compliant product labeling, packaging, and marketing materials
• Coordinate with global partners for international product registrations
• Track and manage regulatory timelines and submissions
• Participate in regulatory inspections and audits

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Key Requirements:
• Bachelor’s degree in life sciences, pharmacy, or a related field (Master’s or PhD a plus)
• 2+ years of experience in regulatory affairs or a similar role
• Strong understanding of regulatory requirements for medical devices, pharmaceuticals, or biologics
• Excellent writing, organizational, and project management skills
• Experience with electronic submission tools (eCTD, RIMS) is a plus

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Benefits:
• Competitive salary with performance-based incentives
• Comprehensive health, dental, and vision insurance
• 401(k) plan with company match
• Paid time off and holidays
• Remote work flexibility (depending on company)
• Career development and certification support

• The Regulatory Affairs Associate, with minimal guidance prepares, reviews and submits high quality annual reports with FDA within Annual report timelines and in accordance with regulatory guidelines and applicable federal laws.
• With minimal guidance, ensure to compile and complete the Annual reports of high-quality, following the regulatory guidelines and internal processes within time lines.
• Coordinate with all supporting departments for obtaining documents for annual report submissions.
• Should archive and maintain all post approval submissions in a systematic way in RA library.
• ssists in Projects Assigned for Post-Approval team (Client, CBE-30, CBE0).
• ssists technical services team by providing required information from the submissions as and when required.
• Organize and maintain submission components associated with a regulatory submission electronically.
• This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress etc. under superior guidance.
• Gain more knowledge in the use of e-CTD structures for submissions.
• Works with colleagues in resolving regulatory issues and/or problem.
• Should archive and maintain all submissions in a systematic way.
• Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
• Maintain current knowledge of regulations and other issues that affect products and industry.
• Maintain the regulatory databases up to date and as per the set criteria.

• Master's degree is Science or Technical, at least 3 Years of experience in Pharmaceutical Industry.
• Regulatory Affairs or related coursework.
• Working knowledge and experience with 21 CFR, US FDA guidance, ICH guidelines.
• Strong computer skills to learn new programs as quickly as possible.
• Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must.
• Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
• bility to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
• Excellent written and verbal communication skills and interpersonal skills.
• bility to communicate effectively and collaboratively as part of a team in a respectful manner.
• bility to work independently, self-starter.
• Good problem-solving skills and analytical ability.
• Strong computer skills to learn new programs as quickly as possible.
• Experience in MS Word, Excel, Outlook, and Adobe Acrobat is a must.

• Provide technical support to sales teams and account managers internally and/or during interactions with clients.
• Support responses to tenders and/or projects from a technical perspective
• Lead and support retailer programs for products within the business unit
• Support tracking of open and incoming order for local C&H laboratory
• Prepare or support the preparation of test plans, test protocols and / or SOPs according to regulatory and/or client requirements
• Train and prepare reports in the area of desktop reviews (ingredient and product label reviews in accordance with applicable US / Canada laws and regulations)
• Lead and support the execution of sensory and consumer panel testing plans
• Stay up to date on applicable and upcoming federal and state laws, hazardous materials regulations, and other applicable US / Canada laws and regulations applicable to cosmetics, personal care and household products
• Create/Review/Send test reports as required
• Additional responsibilities as assigned by supervisor

• Bachelor's degree within a scientific discipline such as chemistry, microbiology, etc Required
• Knowledge / experience of the cosmetics, personal care and/or household care sector Required
• Minimum 1-3 years of relevant experience Required
• Knowledge / experience in cosmetics, personal care or household care related testing services (microbiology, chemical, etc.) desirable Preferred
• Regulatory knowledge / experience desirable Preferred
• Knowledge or understanding of sensory testing Preferred

On-Board Scientific is hiring a Regulatory Affairs Specialist in
West Lake, OH  
For immediate consideration please send your resume to

• Classify new and existing products according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals, including compliance with local regulations such as:
  • U.S. Hazard Communication Standard (HazCom 2012)
  • Canadian WHMIS 2015
• Pre-author Safety Data Sheets (SDS) and labels in accordance with HazCom 2012 and WHMIS 2015
• Support regulatory projects and change management processes
• Respond to basic customer regulatory queries 

• Bachelor’s degree in Chemistry, Biology, Toxicology, or a related field
• Experience in a professional-level role, preferably within a business or regulatory environment
• Familiarity with OSHA, TSCA, RCRA, and Export regulations is desirable
• Background in Industrial Chemical Regulatory Affairs is preferred
• Strong ability to manage multiple projects and effectively communicate progress to senior staff
• Excellent written and verbal communication skills
• Proficient computer skills; experience with SAP is preferred

 
Apply Today!