NewAmsterdam Pharma Corporation
Senior Manager, CMC Regulatory Affairs
Remote - USA, USA · Senior
Sponsorship not specifiedDetected 27 days ago
Product ManagementProject ManagementSupply ChainFDA RegulatoryCommunicationCollaborationGxPRegulatory Affairs
About the role
- NewAmsterdam Pharma is an equal opportunity employer.
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.
- 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 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.
- 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.
- 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.
Requirements
- 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.
- Strong knowledge of FDA regulations, ICH guidelines, and global regulatory requirements related to pharmaceutical development, registration, change control, and post-approval reporting.
- Experience supporting regulatory assessment of manufacturing, analytical, process, specification, facility, packaging, labeling, and supply chain changes.
- Experience with electronic document management systems, submission platforms, and regulatory information management tools.
- Ability to work independently and effectively within cross-functional and global teams.
- Ability to travel domestically and internationally, as required (approximately 5-10%).
Nice to have
- Bachelor's degree in a scientific discipline, Chemistry and advanced degree preferred
- experience with small molecules preferred.
- Experience and understanding of drug substance and drug product development, manufacturing processes, analytical testing, and control strategies
Compensation
- 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 preparation of CMC content for annual reports, regulatory maintenance reports, and other required regulatory updates.
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.
- Support the preparation and coordination of responses to health authority questions, deficiency letters, requests for information, and regulatory commitments
- Support health authority inspections, audits, due diligence activities, and regulatory interactions.
Equal opportunity
- equal opportunity employer.
Apply directly at NewAmsterdam Pharma Corporation →Create a free account for alerts like thisView NewAmsterdam Pharma Corporation immigration profile
This listing is sourced directly from NewAmsterdam Pharma Corporation's careers page and normalized into a canonical job model.