Director, RA Global Regulatory Strategy
BioSpace, Florham Park, NJ, United States
Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas—immunology, oncology, neuroscience, and eye care—and across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.
Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. The role leads the Global Regulatory Product Team (GRPT), expands therapeutic area knowledge, and ensures strategic messaging and content of global regulatory dossiers. Responsibilities include, but are not limited to, leading the Labeling Regulatory Strategy Team (LRST), serving as the primary regulatory interface with AST and supporting teams, proactively anticipating and mitigating regulatory risks, ensuring compliance with global regulatory requirements, managing compounds through all phases of development, demonstrating an excellent understanding of drug development, and managing projects and documentation of regulatory strategies.
Responsibilities
Interface with the LRST and AST to lead and support cross‑functional company objectives, and lead the GRPT to develop creative global strategies aligned with applicable regulations to achieve business objectives for development and marketed products.
Lead cross‑functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory agency requests.
Be accountable for ensuring that corporate goals are met, acting as a key internal leader and driver of regulatory policy and strategy for assigned products.
Prepare global regulatory product strategies for assigned products, proactively leading regulatory and cross‑functional teams in the preparation and maintenance of risk assessment and mitigation strategy development and communicating the plan to relevant stakeholders.
Act independently under the direction of a GRS Sr GRL or TA Head, participate in or lead regulatory and company initiatives, expand knowledge of the therapeutic area, and provide coaching and mentoring for GRPT members. May have direct reports and contribute to performance management for other RA team members.
Influence the development of regulations and guidance, analyze legislation, regulations, and guidance, and provide analysis to the organization with worldwide accountability for assigned products.
Follow company policies and procedures for regulatory record‑keeping, identify the need for and develop and implement policies and procedures within the RA department, and ensure direct reports follow requirements.
Ensure alignment of global regulatory strategies with senior management, present meaningful regulatory assessments and recommendations to executive management, and proactively inform AST and cross‑functional management of issues, labeling outcomes, approval or other risks and mitigations.
Make decisions regarding work processes or operational plans and schedules to achieve program objectives established by senior management, and advance organizational goals by participating in leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
Follow budget allocations and keep supervisor informed on project resourcing (headcount‑related fees, filing fees, and professional services), chair or sponsor key GRS initiatives, and present outcomes to RA LT.
Qualifications
Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
Preferred Education: Relevant advanced degree is preferred; certification is a plus.
Required Experience: 7+ years regulatory experience, including drug development experience in the US and Canada, proven 5+ years in a strategic leadership role with strong project‑management skills, experience working in a complex and matrix environment with multiple stakeholders, and experience interfacing with major government regulatory agencies.
Required Experience (cont’d): Strong communication and proactive negotiation skills; experience developing and implementing successful global regulatory strategies.
Preferred Experience: 10+ years experience in pharmaceutical regulatory activities, experience as lead regulatory product strategist in two or more major regions in addition to the US (e.g., EU or Japan), and a strong global drug development foundation with business acumen.
Note: Higher education may compensate for years of experience.
Additional Information
The compensation range described below is the range of possible base pay for this role at the time of this posting, based on the job grade for this position. Individual compensation within this range will depend on factors including geographic location, and the company may ultimately pay more or less than the posted range. The range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
Equal Opportunity AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. The role leads the Global Regulatory Product Team (GRPT), expands therapeutic area knowledge, and ensures strategic messaging and content of global regulatory dossiers. Responsibilities include, but are not limited to, leading the Labeling Regulatory Strategy Team (LRST), serving as the primary regulatory interface with AST and supporting teams, proactively anticipating and mitigating regulatory risks, ensuring compliance with global regulatory requirements, managing compounds through all phases of development, demonstrating an excellent understanding of drug development, and managing projects and documentation of regulatory strategies.
Responsibilities
Interface with the LRST and AST to lead and support cross‑functional company objectives, and lead the GRPT to develop creative global strategies aligned with applicable regulations to achieve business objectives for development and marketed products.
Lead cross‑functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory agency requests.
Be accountable for ensuring that corporate goals are met, acting as a key internal leader and driver of regulatory policy and strategy for assigned products.
Prepare global regulatory product strategies for assigned products, proactively leading regulatory and cross‑functional teams in the preparation and maintenance of risk assessment and mitigation strategy development and communicating the plan to relevant stakeholders.
Act independently under the direction of a GRS Sr GRL or TA Head, participate in or lead regulatory and company initiatives, expand knowledge of the therapeutic area, and provide coaching and mentoring for GRPT members. May have direct reports and contribute to performance management for other RA team members.
Influence the development of regulations and guidance, analyze legislation, regulations, and guidance, and provide analysis to the organization with worldwide accountability for assigned products.
Follow company policies and procedures for regulatory record‑keeping, identify the need for and develop and implement policies and procedures within the RA department, and ensure direct reports follow requirements.
Ensure alignment of global regulatory strategies with senior management, present meaningful regulatory assessments and recommendations to executive management, and proactively inform AST and cross‑functional management of issues, labeling outcomes, approval or other risks and mitigations.
Make decisions regarding work processes or operational plans and schedules to achieve program objectives established by senior management, and advance organizational goals by participating in leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
Follow budget allocations and keep supervisor informed on project resourcing (headcount‑related fees, filing fees, and professional services), chair or sponsor key GRS initiatives, and present outcomes to RA LT.
Qualifications
Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
Preferred Education: Relevant advanced degree is preferred; certification is a plus.
Required Experience: 7+ years regulatory experience, including drug development experience in the US and Canada, proven 5+ years in a strategic leadership role with strong project‑management skills, experience working in a complex and matrix environment with multiple stakeholders, and experience interfacing with major government regulatory agencies.
Required Experience (cont’d): Strong communication and proactive negotiation skills; experience developing and implementing successful global regulatory strategies.
Preferred Experience: 10+ years experience in pharmaceutical regulatory activities, experience as lead regulatory product strategist in two or more major regions in addition to the US (e.g., EU or Japan), and a strong global drug development foundation with business acumen.
Note: Higher education may compensate for years of experience.
Additional Information
The compensation range described below is the range of possible base pay for this role at the time of this posting, based on the job grade for this position. Individual compensation within this range will depend on factors including geographic location, and the company may ultimately pay more or less than the posted range. The range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
Equal Opportunity AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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