Senior Global Regulatory Strategy Lead – US & Canada (Hybrid)

BioSpace; North Chicago (IL); Hybrid; USD 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Long-term incentive programs

401(k) plan

Paid time off

Zusammenfassung

AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead the development and implementation of US and Canada regulatory strategy for on-market or development-stage products. You will ensure strategies defined within the GRPT are executed, and gather data to support filings and registrations.

The role requires collaboration with FDA and cross-functional teams, experience in complex regulatory environments, and a hybrid schedule (3 days in office, 2 remote) at

Qualifikationen

• Bachelor's degree required in a scientific field; advanced degree a plus.
• Minimum 6 years of regulatory affairs experience in pharma/biotech.
• Experience developing US and Canada regulatory strategies and submissions.
• Ability to work in a complex, matrix environment with cross-functional teams.
• Experience interfacing with government regulatory agencies.

Aufgaben

• Develop and execute regulatory strategy for US/Canada on-market or development products.
• Serve as FDA liaison; prepare briefing packages and responses.
• Lead regulatory submissions and ensure timely reviews in line with guidelines.
• Collaborate across Regulatory, Clinical, Legal and Commercial teams.
• Contribute to training and mentoring of staff; support strategic initiatives.

Kenntnisse

Regulatory strategy

Regulatory submissions

Negotiation

Cross-functional collaboration

Communication skills

Ausbildung

Bachelor's degree in pharmacy, biology, chemistry or related

Jobbeschreibung

AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead the development and implementation of US and Canada regulatory strategy for on-market or development-stage products. You will ensure strategies defined within the GRPT are executed, and gather data to support filings and registrations.

The role requires collaboration with FDA and cross-functional teams, experience in complex regulatory environments, and a hybrid schedule (3 days in office, 2 remote) at