Senior Manager, Regulatory Affairs CMC (Hybrid)

Company Description

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.

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.

Qualifications

Minimum Qualifications:

• 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.
• Note: Higher education may compensate for years of experience

Preferred Qualifications: 

• 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.

Other Required Skills:

• Strong oral and written communication skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive