Director, RA Global Regulatory Strategy
AbbVie
4 months ago
Remote friendly (North Chicago, IL)
United States
$177,000 - $336,000 USD yearly
Corporate Functions
Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval for obesity/metabolic therapeutic area products.
- Lead Global Regulatory Product Team (GRPT) and Labeling Regulatory Strategy Team (LRST); serve as primary regulatory interface with AST and supporting teams.
- Ensure strategic messaging and content of global regulatory dossiers and responses to agency requests.
- Lead cross-functional preparation and maintenance of risk assessments and risk mitigation strategies; proactively anticipate/mitigate regulatory risks.
- Manage compounds through all development phases, including post-approval life cycle.
- Ensure compliance with global regulatory requirements and align strategies with senior management.
- Analyze legislation/regulations/guidance and provide recommendations with worldwide accountability for assigned products.
- Follow and may develop regulatory policies/procedures for record keeping; ensure direct reports comply.
- Present regulatory assessments/recommendations to executive management; inform stakeholders of issues, labeling outcomes, approvals, and mitigations.
- Make decisions on work processes/operational plans and schedules; sponsor/chair key GRS initiatives.
- Manage project resourcing and keep supervisor informed (e.g., filing fees, professional services).
Qualifications:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
- 7+ years regulatory experience; drug development experience in US/C region.
- 5+ years strategic leadership with strong project management.
- Experience in complex matrix environment; influencing cross-functional teams; interfacing with major government regulatory bodies.
- Strong communication and proactive negotiation skills; experience developing and implementing global regulatory strategies.
- Preferred: relevant advanced degree; certification a plus.
- Preferred: 10+ years pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) plus US.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) eligibility.
- Eligible for short-term and long-term incentive programs.
Other:
- Hybrid onsite; based in Lake County, IL or Florham Park, NJ.
- Frequent to continuous computer usage (≥50% of workday).
- Develop and implement global regulatory strategies to secure and maintain market approval for obesity/metabolic therapeutic area products.
- Lead Global Regulatory Product Team (GRPT) and Labeling Regulatory Strategy Team (LRST); serve as primary regulatory interface with AST and supporting teams.
- Ensure strategic messaging and content of global regulatory dossiers and responses to agency requests.
- Lead cross-functional preparation and maintenance of risk assessments and risk mitigation strategies; proactively anticipate/mitigate regulatory risks.
- Manage compounds through all development phases, including post-approval life cycle.
- Ensure compliance with global regulatory requirements and align strategies with senior management.
- Analyze legislation/regulations/guidance and provide recommendations with worldwide accountability for assigned products.
- Follow and may develop regulatory policies/procedures for record keeping; ensure direct reports comply.
- Present regulatory assessments/recommendations to executive management; inform stakeholders of issues, labeling outcomes, approvals, and mitigations.
- Make decisions on work processes/operational plans and schedules; sponsor/chair key GRS initiatives.
- Manage project resourcing and keep supervisor informed (e.g., filing fees, professional services).
Qualifications:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
- 7+ years regulatory experience; drug development experience in US/C region.
- 5+ years strategic leadership with strong project management.
- Experience in complex matrix environment; influencing cross-functional teams; interfacing with major government regulatory bodies.
- Strong communication and proactive negotiation skills; experience developing and implementing global regulatory strategies.
- Preferred: relevant advanced degree; certification a plus.
- Preferred: 10+ years pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) plus US.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) eligibility.
- Eligible for short-term and long-term incentive programs.
Other:
- Hybrid onsite; based in Lake County, IL or Florham Park, NJ.
- Frequent to continuous computer usage (≥50% of workday).