Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)

Job Description

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. The role prepares CMC regulatory strategies that enable first‑pass approvals, develops and manages content strategy for regulatory submissions (INDs/CTAs, amendments, new marketing applications, supplements/variations), builds and maintains relationships within Regulatory Affairs, Operations and R&D, and represents CMC on product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence and provide strategic advice.

This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters.

• Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations, and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions and seeks expert advice and technical support as required.
• 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 product development, Global Regulatory Product Teams and Operations brand teams, negotiating and influencing team members with management support to maximize first‑pass approval chances.
• 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 RA CMC internal initiatives; represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.

• Required
  
  Education:
  
  Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
  
  Preferred Education:
  
  Relevant advanced degree. Certification a plus.
• Required Experience:
  
  8 years of pharmaceutical experience.
  
  Preferred Experience:
  
  10 years of pharmaceutical experience, including 5‑plus years in regulatory affairs or 5‑plus years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing successful global regulatory strategies.
• Experience working in a complex and matrix environment.
• Strong oral and written communication skills.
• Note:
  
  Higher education may compensate for years of experience.

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8‑hour day) is required.

• 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 the posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors, including geographic location, and may ultimately be more or less 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 programs.

Abb Vie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

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