BioSpace
Overview
The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the obesity/metabolic (TA). This role leads the Global Regulatory Product Team (GRPT) and Labeling Regulatory Strategy Team (LRST) and serves as the primary regulatory interface with AST and supporting teams. The position proactively expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. It also develops acceleration strategies and manages compounds through all phases of development, including post-approval and lifecycle management.
Responsibilities
Interface with the LRST and AST to lead and support cross-functional objectives. Lead the GRPT to develop global strategies aligned with regulations to achieve business objectives for development and marketed products. When necessary, seek expert advice from functional stakeholders, supervisors, and TA level personnel.
Lead cross-functional stakeholders and regulatory professionals to ensure clear strategic messaging in global regulatory dossiers and responses to regulatory agency requests.
Accountable for ensuring corporate goals are met. Act as a key internal leader and driver of regulatory policy and strategy for assigned products.
Lead preparation of global regulatory product strategies for assigned products. Proactively lead risk assessment and mitigation strategy development and communicate plans to stakeholders.
Operate independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Based on experience, expand TA knowledge and provide coaching and mentoring for GRPT members. May have direct reports and contribute to performance management for RA team members.
Influence the development of regulations and guidance. Analyze legislation and guidance with worldwide accountability for assigned products.
Ensure alignment of global regulatory strategies with Sr. Management. Present meaningful regulatory assessments and recommendations to executive management under minimal supervision. Proactively inform AST and cross-functional management of issues, labeling outcomes, approvals, risks, and mitigations; assess impact on global programs. Represent ABBV Regulatory position in Joint Governance interactions.
Make decisions regarding work processes or operational plans to achieve program objectives. Contribute to professional associations and industry groups as appropriate for projects.
Manage budget considerations and keep supervision informed on project resourcing. 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; certification a plus.
Required Experience: 7+ years of regulatory experience; drug development experience in US & Canada region. Proven 5+ years in a strategic leadership role with strong project management in a complex, matrix environment. Experience interfacing with major government regulatory bodies.
Strong communication and proactive negotiation skills. Experience developing and implementing global regulatory strategies.
Preferred Experience: 10+ years in pharmaceutical regulatory activities with lead regulatory product strategist experience in two or more major regions (e.g., EU, Japan) in addition to the US. Strong global development foundation with business acumen. Higher education may compensate for years of experience.
Additional Information
Hybrid onsite opportunity. Role can be based in AbbVie’s Lake County, IL or Florham Park, NJ offices.
Frequent computer usage required (≥50% of workday).
We offer a comprehensive benefits package and eligible employees may participate in short- and long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to integrity, innovation, and serving the community. EEO statements apply.
Legal and location specific disclosures: US & Puerto Rico users can learn more about equal employment opportunities and reasonable accommodations via AbbVie links provided in the posting.
#J-18808-Ljbffr
Responsibilities
Interface with the LRST and AST to lead and support cross-functional objectives. Lead the GRPT to develop global strategies aligned with regulations to achieve business objectives for development and marketed products. When necessary, seek expert advice from functional stakeholders, supervisors, and TA level personnel.
Lead cross-functional stakeholders and regulatory professionals to ensure clear strategic messaging in global regulatory dossiers and responses to regulatory agency requests.
Accountable for ensuring corporate goals are met. Act as a key internal leader and driver of regulatory policy and strategy for assigned products.
Lead preparation of global regulatory product strategies for assigned products. Proactively lead risk assessment and mitigation strategy development and communicate plans to stakeholders.
Operate independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Based on experience, expand TA knowledge and provide coaching and mentoring for GRPT members. May have direct reports and contribute to performance management for RA team members.
Influence the development of regulations and guidance. Analyze legislation and guidance with worldwide accountability for assigned products.
Ensure alignment of global regulatory strategies with Sr. Management. Present meaningful regulatory assessments and recommendations to executive management under minimal supervision. Proactively inform AST and cross-functional management of issues, labeling outcomes, approvals, risks, and mitigations; assess impact on global programs. Represent ABBV Regulatory position in Joint Governance interactions.
Make decisions regarding work processes or operational plans to achieve program objectives. Contribute to professional associations and industry groups as appropriate for projects.
Manage budget considerations and keep supervision informed on project resourcing. 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; certification a plus.
Required Experience: 7+ years of regulatory experience; drug development experience in US & Canada region. Proven 5+ years in a strategic leadership role with strong project management in a complex, matrix environment. Experience interfacing with major government regulatory bodies.
Strong communication and proactive negotiation skills. Experience developing and implementing global regulatory strategies.
Preferred Experience: 10+ years in pharmaceutical regulatory activities with lead regulatory product strategist experience in two or more major regions (e.g., EU, Japan) in addition to the US. Strong global development foundation with business acumen. Higher education may compensate for years of experience.
Additional Information
Hybrid onsite opportunity. Role can be based in AbbVie’s Lake County, IL or Florham Park, NJ offices.
Frequent computer usage required (≥50% of workday).
We offer a comprehensive benefits package and eligible employees may participate in short- and long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to integrity, innovation, and serving the community. EEO statements apply.
Legal and location specific disclosures: US & Puerto Rico users can learn more about equal employment opportunities and reasonable accommodations via AbbVie links provided in the posting.
#J-18808-Ljbffr