Job Description:
NewAmsterdam Pharma (NAP) is seeking a Senior Manager CMC Regulatory Affairs is responsible for supporting the development and execution of global CMC regulatory strategies for clinical development programs, initial marketing applications (NDA, MAA, ANDA), and post-approval lifecycle management activities. The role provides strategic and operational support for the preparation, review, and submission of high-quality CMC regulatory dossiers while ensuring compliance with global regulatory requirements. This is a remote position with team building and conference travel expected and will report to the Senior Director CMC Regulatory Affairs.
Key Responsibilities:
- Support the development and execution of global CMC regulatory strategies for clinical development programs and initial marketing applications, in alignment with business objectives and regulatory requirements.
- Lead post-approval CMC regulatory lifecycle management activities, including strategy development and execution for variations, supplements, renewals, annual reports, and other post-approval submissions.
- Support the preparation, review, compilation, maintenance, and submission of CMC regulatory dossiers (Modules 2.3 and 3) and related documentation for clinical and commercial products, including INDs, IMPDs, CTAs, NDAs, MAAs, amendments, and lifecycle management submissions.
- Support the preparation and coordination of responses to health authority questions, deficiency letters, requests for information, and regulatory commitments
- Support cross-functional collaboration with Technical Operations, Manufacturing, Analytical Development, Quality Assurance, Supply Chain, and external partners to ensure timely execution of CMC regulatory strategies, submissions, and post-approval commitments.
- Maintain regulatory documentation systems and repositories, ensuring version control, traceability, inspection readiness, and compliance.
- Perform change control assessments and regulatory impact evaluations to determine appropriate filing strategies and reporting requirements globally.
- Collaborate with cross-functional teams to support regulatory assessments and filing strategies for manufacturing, analytical, process, specification, facility, packaging, labeling, and supply chain changes.
- Monitor evolving global regulatory requirements and support implementation of regulatory strategies to maintain compliance throughout the product lifecycle.
- Ensure timely delivery of high-quality, submission-ready regulatory packages that meet project timelines and regulatory milestones.
- Support health authority inspections, audits, due diligence activities, and regulatory interactions.
- Support preparation of CMC content for annual reports, regulatory maintenance reports, and other required regulatory updates.
- Support vendor and CRO management activities to ensure timely delivery of CMC regulatory documentation and submission deliverables.
- Support continuous improvement of regulatory processes, documentation standards, templates, and submission workflows.
- Serve as a CMC regulatory representative on cross-functional project teams.
Requirements:
- Bachelor's degree in a scientific discipline, Chemistry and advanced degree preferred
- 8 years in the pharmaceutical industry, with a minimum of 6 years in Regulatory.
- Proven experience supporting CMC regulatory submissions, including INDs, IMPDs, CTAs, NDAs, MAAs, ANDAs, and post-approval lifecycle management activities.
- Experience supporting global regulatory filings and interactions with health authorities, including FDA, EMA, and other international regulatory agencies.
- Strong knowledge of FDA regulations, ICH guidelines, and global regulatory requirements related to pharmaceutical development, registration, change control, and post-approval reporting.
- Solid understanding of GxP standards, quality systems, policies, and procedures.
- Experience supporting regulatory assessment of manufacturing, analytical, process, specification, facility, packaging, labeling, and supply chain changes.
- Experience and understanding of drug substance and drug product development, manufacturing processes, analytical testing, and control strategies; experience with small molecules preferred.
- Experience working with CMOs, CDMOs, and external regulatory partners.
- Experience with electronic document management systems, submission platforms, and regulatory information management tools.
- Excellent verbal, written, and interpersonal communication skills.
- Strong project management and organizational skills.
- Collaborative problem-solver with the ability to assess regulatory risks and develop practical solutions.
- Ability to work independently and effectively within cross-functional and global teams.
- Experience supporting regulatory inspections, audits, due diligence activities, and health authority interactions is preferred.
- Ability to travel domestically and internationally, as required (approximately 5–10%).
Salary and Benefits:
We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.
NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.
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