Manager Regulatory Affairs, Global Regulatory Strategy US & Canada - Hybrid
About The Position
The Manager Regulatory Affairs, Global Regulatory Strategy US & Canada develops and implements regulatory strategic and tactical planning for assigned products in the United States and Canada, including products already on the market and those in development. The role gathers and evaluates data to support regulatory filings, responses to inquiries, and registration maintenance, enabling commercialization in compliance with applicable requirements. The position supports regulatory strategy and execution for products within a therapeutic area, contributes to submission preparation and review, supports the submission and approval process, and serves as an FDA liaison for routine filing communications. It advises internal stakeholders on regulatory matters, applies regulatory and technical expertise across therapeutic areas, and recommends project changes based on regulatory requirements, guidance, and company policies. The role works with cross-functional teams and operates in compliance with regulations and the Quality Dossier Program. This is a hybrid position based at AbbVie's Lake County, Illinois headquarters, with three days in the office.
Requirements
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or an industry-related field.
- At least 6 years of regulatory, R&D, or industry-related experience.
- Proven ability to implement successful US and Canada regulatory strategies.
- Experience working in a complex, matrixed environment.
- Good oral and written communication skills.
- Experience interfacing with government regulatory agencies.
- Good negotiation skills and ability to build consensus.
Nice To Haves
- Advanced degree.
- Certifications.
- Two to three years of experience in pharmaceutical regulatory activities.
- Global regulatory experience.
Responsibilities
- Support the development and execution of regulatory strategy for assigned product(s) within a therapeutic area.
- Develop and implement US and Canada regulatory strategic and tactical planning for assigned marketed or developmental products.
- Identify and gather data needed to support filings, responses to inquiries, and registration maintenance.
- Serve as the Health Authority liaison with the FDA for routine filing communications, including complete and timely responses during application review.
- Advise internal customers, including Public Affairs, Clinical Development, Legal, and Commercial, on regulatory and FDA issues related to regulated communications.
- Independently negotiate and make decisions on project-related issues with cross-functional impact.
- Prepare and review regulatory submissions in accordance with US and Canada regulatory requirements and guidelines, and ensure timely and complete responses to Health Authorities during application review.
- Support the regulatory submission and approval process.
- Apply regulatory and technical knowledge of government regulations across therapeutic areas.
- Recommend and implement project changes based on interpretation of US and Canada regulations and guidance, corporate policies, and management considerations.
- Present relevant regulatory information to appropriate cross-functional groups.
- Operate in compliance with regulations, company policies, procedures, guidance, regulatory product strategy, and the Quality Dossier Program.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
