Associate Director, RA CMC Pipeline (Hybrid Onsite)

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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including new marketing applications, supplements and variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research and Development groups. Manages products and change controls in compliance with regulations and company policies and procedures. Represents CMC on teams such as Product Development, Global Regulatory Project Teams and Operations teams to negotiate, influence, and provide strategic advice. Serves as liaison and strategic partner with FDA. Manages assigned projects within assigned resources. May manage, coach, mentor, and develop junior staff, including new employee onboarding.

Responsibilities:

• Prepares CMC regulatory product strategies. Seeks expert advice, regulatory intelligence and technical support as required for strategies and submissions
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of briefing documents
• Regularly informs regulatory management of important timely issues
• Manages preparation of CMC submissions. Prepares and manages regulatory applications, including new applications and amendments, renewals, annual reports, supplements and variations
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
• Identify and communicate content gaps and risks for submissions
• Manages change control in compliance with regulations and company policies and procedures. Analyzes and approves CMC change requests.
• Trains, develops and mentors individuals; may include formal supervisory responsibilities
• Develops and implements policies and procedures within the regulatory affairs department
• Analyzes legislation, regulation and guidance, provides analysis to the organization
• Provides tactical support to integrate technical issues with regulatory requirements and emerging standards

This role is a hybrid onsite opportunity. The individual can be based in AbbVie's Irvine, CA, Lake County, IL, or Florham Park, NJ locations. 

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline 
• Required: 8 years pharmaceutical experience
• Preferred: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing, 2-plus years supervising employees  
• Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions
• Strong working knowledge of manufacturing unit operations or CTD structure
• Superior oral and written communication skills 
• Ability to work cooperatively with all levels and types of global personnel required 
• Experience working with electronic document management systems 
• Ability to work independently under pressure and manage multiple projects simultaneously 
• Detail/accuracy oriented 
• Collaborative and willing to learn  
• Familiarity with US and other international regulatory requirements for drug product dossiers 

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

​

• 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 short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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 AbbVie’s 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html