Director, RA CMC

Company Description

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, ()  Facebook, Instagram () , X ()  and You Tube.

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Job Description

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

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

+ 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…