Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
About The Position
The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. This role is responsible for preparing CMC regulatory strategies that enable first pass approvals, and for developing and managing the content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications, and supplements/variations. The position involves building and maintaining relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. The Senior Manager will represent CMC on various teams such as product development, Global Regulatory Product Teams, and Operations brand teams, to negotiate, influence, and provide strategic advice.
Requirements
- Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
- 8 years pharmaceutical experience.
- Experience developing and implementing successful global regulatory strategies.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
Nice To Haves
- Relevant advanced degree preferred.
- Certification a plus.
- 10 years pharmaceutical experience.
- 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
Responsibilities
- Prepares CMC regulatory product strategies.
- Prepares and manages regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations, and responds to regulatory information requests.
- Analyzes and interprets information that impacts regulatory decisions, seeking expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
- Responds to global regulatory information requests.
- Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
- Manages products and change control with an understanding of regulations and company policies and procedures.
- Analyzes and approves manufacturing change requests.
- Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in regulatory climate.
- Analyzes legislation, regulation and guidance, and provides analysis to the organization.
- Develops, implements, and documents policies and procedures within the regulatory affairs department.
- Participates in initiatives internal to RA CMC.
- Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- long-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
