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

About the role

The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver biologics products to patients, including mAbs, ADCs, and cell & gene therapies. This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters.

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.
• Analyzes and interprets information that impacts regulatory decisions.
• Sets and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications, and supplements/variations.
• Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations.
• Represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice.
• 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, 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.

Qualifications

• Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology, or Pharmacology, Engineering, or related subject.
• Preferred Education: Relevant advanced degree preferred.
• Required Experience: 8 years pharmaceutical experience, including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
• Preferred Experience: 10 years 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.

Additional Information

Note: Higher education may compensate for years of experience. This role is eligible to participate in AbbVie's long-term incentive programs. AbbVie 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. For more information, visit here. For reasonable accommodations, visit here.