Senior Regulatory Strategy Lead - US & Canada (Hybrid)

Regulatory Jobs; Irvine (CA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

AbbVie in the United States is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead the development and execution of regulatory strategies for on-market products and development programs. You will coordinate submissions, liaise with FDA, and guide cross-functional teams to ensure timely compliance and filings.

The role requires strong negotiation and communication skills, extensive regulatory knowledge, and experience in a complex matrix environment.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology.
• Minimum of 6 years of experience in regulatory affairs.
• Excellent negotiation and communication skills.
• Experience interfacing with government regulatory agencies.

Responsibilities

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
• Functions independently in negotiation and decision-making for project related issues that have crossfunctional impact. Assists in the development,training of staff members.
• Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
• Presents pertinent regulatory information to appropriate cross-functional areas.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
• This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, IL; Florham Park, NJ or Irvine, CA AbbVie headquarters.

Skills

Regulatory strategy

FDA liaison

Cross-functional collaboration

Negotiation

Education

Bachelor’s degree in pharmacy, biology, chemistry, pharmacology

Job description

AbbVie in the United States is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead the development and execution of regulatory strategies for on-market products and development programs. You will coordinate submissions, liaise with FDA, and guide cross-functional teams to ensure timely compliance and filings.

The role requires strong negotiation and communication skills, extensive regulatory knowledge, and experience in a complex matrix environment.