Regulatory Strategy Lead, US & Canada (Hybrid)

Allergan; Florham Park (NJ); Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

Long-term incentive programs

401(k)

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy and execution for on-market products or those in development. You will partner with cross-functional teams to ensure compliant filings and timely responses to Health Authorities.

The role requires strong negotiation and communication skills, experience with regulatory submissions, and the ability to operate in a complex matrix environment, with a hybrid work setup in Florham Park, NJ.

Qualifications

• Bachelor's degree (pharmacy, biology, chemistry, pharmacology or related).
• Excellent negotiation and communication skills.
• Experience in regulatory affairs in a complex matrix environment.
• Experience interfacing with government regulatory agencies.

Responsibilities

• Serve as HA liaison and interface with FDA for meetings and briefing packages.
• Develop and implement US & Canada regulatory strategy and planning.
• Prepare regulatory submissions and ensure timely responses to Health Authorities.
• Advise internal customers on Regulatory/FDA issues including Public Affairs, Clinical Development and Legal.
• Contribute to training staff and cross-functional collaboration on regulatory matters.
• Present regulatory information to cross-functional teams and ensure compliance with QDP guidelines.

Skills

Negotiation

Communication

Cross-functional collaboration

Education

Bachelor's degree (pharmacy, biology, chemistry, pharmacology or related)

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy and execution for on-market products or those in development. You will partner with cross-functional teams to ensure compliant filings and timely responses to Health Authorities.

The role requires strong negotiation and communication skills, experience with regulatory submissions, and the ability to operate in a complex matrix environment, with a hybrid work setup in Florham Park, NJ.