Director, RA CMC

Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)

The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops 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 and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers and management in RA, R&D, and Operations. Serves as strategic liaison with regulatory agencies (e.g., FDA) regarding CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.

Responsibilities

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new IND/CTA applications and amendments, new marketing authorization submissions, renewals, annual reports, supplements and variations, and/or leads a global RA CMC team who develops strategies for development and marketed products
• Advises internal personnel on regulatory strategies. Provides strategic regulatory advice to peers and management in RA, R&D, and Operations. Seeks internal and external expert advice and technical support when necessary.
• Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies. Devises regulatory strategies for complicated scenarios (e.g., complex dosage form or multiple operational changes, aggressive timelines).
• Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages. Serves as the point of contact for the regulatory agency meetings and leads CMC discussion for projects with health authorities. Drives strategic change planning with Manufacturing Operations using a risk-based approach centered on assessment of potential impact to quality, safety or efficacy.
• Manages products and change control in compliance with an understanding of regulations, guidances and company policies and procedures. Analyzes and approves manufacturing change records.
• Represents RA CMC on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions
• Stays abreast of regulatory procedures and changes in external regulatory environment. Analyzes legislation, regulation and guidance and provides analysis to the organization. Leads creation of white papers and policies to illustrate current regulatory thinking.
• Designs initiatives to drive business efficiencies across the organization (within or outside of the regulatory groups). Ensures enterprise culture initiatives are implemented across RA CMC.
• Trains, develops and mentors individuals; may include formal supervisory responsibilities of product leads. Evaluates performance of and assists in career development planning for assigned staff.

Qualifications

• Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• Preferred Education: Relevant advanced degree preferred. Certification a plus
• Required Experience: 10 years biopharmaceutical experience with 3-plus years demonstrated enterprise leadership. 5-plus years in RA or relevant exposure to RA activities
• Preferred Experience: 10-plus years biopharmaceutical RA, R&D, or Operations experience, including 7-plus years in regulatory affairs
• Experience developing and implementing successful global regulatory strategies
• Interfacing ability with government regulatory agencies
• Success leading in a complex and matrix environment.
• Strong understanding of the business/enterprise
• Strong oral and written communication skills.

Additional Information

• 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 posting based 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 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.

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.