Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
About The Position
The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada develops and implements US and Canada regulatory strategic and tactical planning for assigned products on the market or in development. The role ensures that regulatory strategies defined within the Global Regulatory Product Team are implemented and maintained in alignment with evolving regulatory and business needs. The position identifies and gathers information needed to support regulatory filings, responses to inquiries, and registration maintenance so products can be commercialized in compliance with relevant US and Canada regulatory requirements. The role is responsible for one or more products, potentially with multiple driver indications within a therapeutic area, and supports a Manager, Global Regulatory Lead, Associate Director, or Director in developing and executing regulatory strategy. It serves as a Health Authority liaison, interfaces with the FDA, and coordinates FDA meeting preparation, briefing packages, and responses. The Senior Manager contributes to regulatory submissions and approval processes, advises internal stakeholders on regulatory matters, and independently negotiates and makes project decisions with cross-functional impact. The position operates in compliance with regulations, company policies, procedures, guidance, regulatory product strategy, and the Quality Dossier Program. It follows a hybrid schedule of three days in the office and two days remotely, based at an AbbVie headquarters in Lake County, Illinois; Florham Park, New Jersey; Cambridge, Massachusetts; or Irvine, California. Continuous sitting for prolonged periods (more than two consecutive hours in an eight-hour day) is required.
Requirements
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or an industry-related field.
- At least six years of experience in regulatory affairs, research and development, or a related pharmaceutical industry field.
- At least two to three years of experience performing pharmaceutical regulatory activities.
- Excellent negotiation and problem-solving skills, with the ability to build consensus.
- Effective written and oral communication skills within Regulatory and across the organization.
- Ability to deliver challenging messages effectively without compromising important business relationships.
- Demonstrated skill in implementing successful US and Canada regulatory strategies.
- Experience working in a complex, matrixed environment.
- Experience interfacing with government regulatory agencies.
Nice To Haves
- Advanced degree.
- Certifications.
- Global regulatory experience.
Responsibilities
- Develop and implement US and Canada regulatory strategic and tactical plans for assigned products on the market or in development.
- Ensure regulatory strategies defined within the Global Regulatory Product Team are effectively implemented and maintained in response to changing regulatory and business needs.
- Support the Manager, Global Regulatory Lead, Associate Director, or Director in developing and executing regulatory strategy for assigned products.
- Serve as a Health Authority liaison and interface with the FDA for meetings and teleconferences.
- Coordinate preparation and completion of FDA meeting briefing packages and responses.
- Advise internal stakeholders, including Public Affairs, Clinical Development, Legal, and Commercial, on regulatory and FDA matters.
- Independently negotiate and make decisions on project-related issues with cross-functional impact.
- Assist with development and training of staff members.
- Prepare and review regulatory submissions in accordance with US and Canada requirements and guidelines, and ensure complete, timely responses to Health Authorities during application review.
- Support the regulatory submission and approval process.
- Recommend and implement changes to difficult projects based on regulatory knowledge, interpretation of US and Canada regulations and guidance, and corporate policies and management considerations.
- Present relevant regulatory information to appropriate cross-functional areas.
- Operate in compliance with regulations, company policies, procedures, guidance, regulatory product strategy, and the Quality Dossier Program.
- Identify and gather data needed for filings, responses to inquiries, and registration maintenance.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
