Director, Regulatory Affairs CMC

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Job description

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

The Director 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 in RA, R&D, and Operations. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters. Manages assigned projects within assigned resources. May supervise others.

Qualifications

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations.
• Advises internal personnel on regulatory strategies. Provides strategic regulatory advice to peers in RA, R&D, and Operations. Seeks internal and external expert advice and technical support when necessary. Reviews and revises regulatory submissions 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 agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings and leads CMC discussion for projects with health authorities.
• Manages products and change control in compliance 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 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 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.

Qualifications:

Required Education: Bachelors degree in pharmacy, biology, chemistry, pharmacology, engineering or
related subject
Preferred Education: Relevant advanced degree preferred. Certification a plus
Required Experience: 10 years pharmaceutical experience with 3-plus years demonstrated leadership.
Preferred Experience: 10-plus years pharmaceutical experience, including 7-plus years in regulatory affairs,
7-plus years in Discovery, R&D, or Manufacturing
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.
Note: Higher education may compensate for years of experience.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

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

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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