Manager Regulatory Affairs, Global Reg Strategy US & Canada
AbbVie
14 hours ago
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
Corporate Functions
Manager Regulatory Affairs, Global Reg Strategy US & Canada
Responsibilities:
- Develop and implement US/Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Identify and gather data to support filings, inquiries, and registration maintenance to meet US/Canada regulatory requirements.
- Advise on US/Canada region-specific requirements and assess R&D programs against those requirements.
- Serve as Health Authority liaison with FDA for routine communications and complete, timely responses during application review.
- Prepare/review regulatory submissions; support regulatory submission and approval processes.
- Recommend and implement project changes based on accurate interpretation of regulations/guidances and corporate policies.
- Present regulatory information to cross-functional teams; operate in compliance with regulations and the Quality Dossier Program (QDP).
- Hybrid work: 3 days in office (Lake County, IL headquarters).
Work activity: Continuous sitting >2 consecutive hours in an 8-hour day.
Qualifications:
Required:
- Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry-related.
- 6 years Regulatory, R&D, or industry-related experience.
Preferred:
- Advanced degree.
- 2–3 years in pharmaceutical regulatory activities.
- Proven experience implementing US/Canada regulatory strategies; global regulatory experience a plus.
- Experience in complex/matrix environments; strong oral and written communication.
- Experience interfacing with government regulatory agencies; negotiation and consensus-building skills.
- Certifications a plus.
Benefits (explicit): paid time off; medical/dental/vision insurance; 401(k) (eligible employees); short-term incentive program eligibility.
Responsibilities:
- Develop and implement US/Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Identify and gather data to support filings, inquiries, and registration maintenance to meet US/Canada regulatory requirements.
- Advise on US/Canada region-specific requirements and assess R&D programs against those requirements.
- Serve as Health Authority liaison with FDA for routine communications and complete, timely responses during application review.
- Prepare/review regulatory submissions; support regulatory submission and approval processes.
- Recommend and implement project changes based on accurate interpretation of regulations/guidances and corporate policies.
- Present regulatory information to cross-functional teams; operate in compliance with regulations and the Quality Dossier Program (QDP).
- Hybrid work: 3 days in office (Lake County, IL headquarters).
Work activity: Continuous sitting >2 consecutive hours in an 8-hour day.
Qualifications:
Required:
- Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry-related.
- 6 years Regulatory, R&D, or industry-related experience.
Preferred:
- Advanced degree.
- 2–3 years in pharmaceutical regulatory activities.
- Proven experience implementing US/Canada regulatory strategies; global regulatory experience a plus.
- Experience in complex/matrix environments; strong oral and written communication.
- Experience interfacing with government regulatory agencies; negotiation and consensus-building skills.
- Certifications a plus.
Benefits (explicit): paid time off; medical/dental/vision insurance; 401(k) (eligible employees); short-term incentive program eligibility.