This position will lead the Chemistry Manufacturing and Controls (CMC) Regulatory strategy for products in development through post-approval. In this capacity, the incumbent will provide product strategy and direction to R&D, technical operations and commercial teams. Incumbent will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and is accountable for the timely delivery of high-quality regulatory CMC submissions.
Experience working in a matrix environment and excellent people skills are required.
location: Bridgewater, New Jersey
job type: Permanent
salary: $100,000 - 140,000 per year
work hours: 9 to 5
- Lead regulatory CMC strategy development, planning and implementation for multiple development programs. Work with project teams to identify risk areas and associated mitigation plans.
- Act as the regulatory point of contact for assigned projects.
- Work with cross-functional team to plan and prepare FDA meeting briefing documents for assigned projects; draft CMC contributions to meeting requests and briefing documents
- Accountable for file-ability and approvability of CMC filings through involvement at all steps of dossier (eCTD) authoring, review, approval for:
- IND or CTA (IMPD) applications for drug or combination products
- New marketing applications for drugs or combination products
- License Maintenance: post approval changes, recurrent filings: annual reports, etc
- Query responses
- Provide regulatory support to the technical, marketing and quality assurance teams with change controls, labeling and packaging review, etc. to ensure compliance.
- Lead contact and interface with Health Authorities and partners on CMC topics
- Support the Regulatory Affairs group in the development of department SOPs or review of assigned SOPs
- Bachelor's degree in a scientific field required.
- Minimum of 5 years regulatory CMC experience with experience in leading CMC submissions
- Experience with development and registration of parenteral products.
- Strong regulatory project management skills and attention to detail required.
- Excellent written and verbal communication skills essential.
- Proven ability to negotiate, influence and problem solve.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.