Director, RA Global Regulatory Strategy
AbbVie
5 hours ago
Remote friendly (North Chicago, IL)
United States
Corporate Functions
Director Regulatory Affairs Global Regulatory Lead (GRL I) – Global Regulatory Strategy
Role Responsibilities
- Develop and implement global regulatory strategies to secure and maintain market approval for products in assigned therapeutic area.
- Lead the Global Regulatory Product Team (GRPT); may include Area Lead (US/Canada) responsibilities.
- May lead the Labeling Regulatory Strategy Team (LRST).
- Ensure strategic messaging in global regulatory dossiers and responses to regulatory agencies.
- Serve as primary regulatory interface with AST and supporting teams; ensure compliance with global regulatory requirements.
- Manage compounds through all development phases, including post-approval and throughout product lifecycle.
- Develop and implement acceleration strategies.
Additional Responsibilities
- Interface with LRST and AST to implement cross-functional objectives; lead GRPT to create global strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure appropriate strategic messaging in regulatory dossiers and agency responses.
- Lead preparation/maintenance of global regulatory product strategies; lead risk assessment and mitigation strategy development and communicate plans to stakeholders.
- Analyze legislation, regulations, and guidance and provide organization-wide analysis for assigned products.
- Ensure regulatory record-keeping compliance and may develop RA policies/procedures.
- Present regulatory assessments/recommendations to executive management; inform AST/management of issues, risks, and mitigations; assess impact on global programs.
- Make decisions on work processes/operational plans and schedules; manage resourcing consistent with budget allocations.
Qualifications
- Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology or related).
- Preferred Education: Relevant advanced degree; certification a plus.
- Required Experience: 5+ years regulatory experience; 3+ years in strategic leadership with strong project management; experience in complex matrix environment; experience interfacing with government regulatory agencies.
- Required Skills: Strong communication and proactive negotiation; business acumen; ability to work under pressure.
- Preferred Experience: 7+ years pharmaceutical regulatory activities (preferably 2+ regions/major countries); experience developing/implementing global regulatory strategies; drug development and strong clinical foundation preferred.
Benefits
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) (eligible employees).
- Eligible for short-term incentive programs.
Application Instructions
- Not specified in provided text.
Role Responsibilities
- Develop and implement global regulatory strategies to secure and maintain market approval for products in assigned therapeutic area.
- Lead the Global Regulatory Product Team (GRPT); may include Area Lead (US/Canada) responsibilities.
- May lead the Labeling Regulatory Strategy Team (LRST).
- Ensure strategic messaging in global regulatory dossiers and responses to regulatory agencies.
- Serve as primary regulatory interface with AST and supporting teams; ensure compliance with global regulatory requirements.
- Manage compounds through all development phases, including post-approval and throughout product lifecycle.
- Develop and implement acceleration strategies.
Additional Responsibilities
- Interface with LRST and AST to implement cross-functional objectives; lead GRPT to create global strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure appropriate strategic messaging in regulatory dossiers and agency responses.
- Lead preparation/maintenance of global regulatory product strategies; lead risk assessment and mitigation strategy development and communicate plans to stakeholders.
- Analyze legislation, regulations, and guidance and provide organization-wide analysis for assigned products.
- Ensure regulatory record-keeping compliance and may develop RA policies/procedures.
- Present regulatory assessments/recommendations to executive management; inform AST/management of issues, risks, and mitigations; assess impact on global programs.
- Make decisions on work processes/operational plans and schedules; manage resourcing consistent with budget allocations.
Qualifications
- Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology or related).
- Preferred Education: Relevant advanced degree; certification a plus.
- Required Experience: 5+ years regulatory experience; 3+ years in strategic leadership with strong project management; experience in complex matrix environment; experience interfacing with government regulatory agencies.
- Required Skills: Strong communication and proactive negotiation; business acumen; ability to work under pressure.
- Preferred Experience: 7+ years pharmaceutical regulatory activities (preferably 2+ regions/major countries); experience developing/implementing global regulatory strategies; drug development and strong clinical foundation preferred.
Benefits
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) (eligible employees).
- Eligible for short-term incentive programs.
Application Instructions
- Not specified in provided text.