Senior Manager, Regulatory Affairs CMC (Hybrid)
About The Position
About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Senior Manager, Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), works with internal stakeholders and external partners to deliver products to patients. This individual prepares CMC regulatory strategies that enable first pass approvals. The Senior Manager develops and manages the content strategy for regulatory submissions, which include INDs, CTAs, amendments, new marketing applications, and supplements or variations. They build and maintain relationships within the Regulatory Affairs functional areas, as well as Operations and Research & Development (R&D) organizations. The Senior Manager represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams, where they negotiate, influence, and provide strategic advice.
Requirements
- Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
- 8 years of pharmaceutical experience
- Experience developing and implementing successful global regulatory strategies.
- Experience working in a complex and matrix environment.
Nice To Haves
- Relevant advanced degree preferred.
- Certification a plus.
- 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
- Strong oral and written communication skills.
Responsibilities
- Prepares CMC regulatory product strategies.
- Prepares, manages, reviews, and revises regulatory submissions, including new applications, amendments, renewals, annual reports, supplements, and variations, ensuring data and strategy are effectively presented to regulatory agencies and compliance is maintained.
- Responds to regulatory information and global regulatory information requests as required.
- Analyzes and interprets information that impacts regulatory decisions, including manufacturing change requests and regulatory procedures, and stays abreast of regulatory climate changes.
- Seeks expert advice and technical support for developing regulatory strategies and preparing submissions.
- Develops strategies for CMC agency meetings, manages preparation, and oversees the content of pre-meeting submissions.
- Manages products and change control according to applicable regulations and company policies, and approves manufacturing change requests.
- Represents CMC regulatory affairs on cross-functional teams and project initiatives, such as product development, Global Regulatory Product Teams, and Operations brand teams, negotiating and influencing team members to maximize first pass approval chances.
- Develops, implements, and documents policies and procedures within the regulatory affairs department and participates in initiatives internal to Regulatory Affairs CMC.
- Analyzes legislation, regulation, and guidance, and provides relevant analysis to the organization.
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
Mid Level
