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 individual leads the Global Regulatory Product Team (GRPT) and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Continuously expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. Proactively anticipates and mitigates regulatory risks. Ensures compliance with Global regulatory requirements. Manages compounds in the obesity TA through all phases of development, including post approval and through the life cycle of the product. Demonstrates excellent understanding of drug development in the obesity/metabolic TA and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies. This is a hybrid onsite opportunity. The role has flexibility to be based in AbbVie's Lake County, IL or Florham Park, NJ offices. Frequent to continuous computer usage (greater or equal to 50% of the workday) is required Responsibilities
Interfaces with the LRST and AST to lead and support cross-functional company objectives. Lead the GRPT to develop global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seek expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel. 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. Accountable for ensuring that corporate goals are met. 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 regulatory and cross-functional teams in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicate plan to relevant stakeholders. Act independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expand knowledge of TA and provide coaching and mentoring for GRPT members. May have direct report(s) 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 and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements. Ensure alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, present meaningful regulatory assessments and recommendations to executive management. Proactively inform AST and cross functional management of issues, labeling outcomes, approval risks and mitigations. Provide assessment of impact on global programs. Represent ABBV Regulatory position in interactions at Joint Governance. Make decisions regarding work processes or operational plans and schedules to achieve program objectives established by senior management. Advance the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Follow budget allocations and keep supervisor informed on project resourcing. Chairs or sponsors key GRS initiatives and presents 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 a plus. Required Experience: 7+ years regulatory experience with drug development experience in US&C region. Proven 5+ years in strategic leadership with strong project management skills. Experience in a complex, matrix environment with multiple stakeholders and cross-functional influence. Experience interfacing with major government regulatory bodies. Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies. Preferred Experience: 10+ years in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions (US, EU, Japan, etc.). Strong global development foundation with business acumen. Additional Information
Applicable to positions with pay disclosure requirements under state/local law: compensation ranges are described as the range of possible base pay, subject to geographic location and other factors. Individual compensation paid within this range will depend on many factors and may be modified in the future. Benefits include paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. This job is eligible for short-term and long-term incentive programs. AbbVie is an equal opportunity employer. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only – for more information, see AbbVie join-us pages on equal employment opportunity and reasonable accommodations.
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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 individual leads the Global Regulatory Product Team (GRPT) and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Continuously expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. Proactively anticipates and mitigates regulatory risks. Ensures compliance with Global regulatory requirements. Manages compounds in the obesity TA through all phases of development, including post approval and through the life cycle of the product. Demonstrates excellent understanding of drug development in the obesity/metabolic TA and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies. This is a hybrid onsite opportunity. The role has flexibility to be based in AbbVie's Lake County, IL or Florham Park, NJ offices. Frequent to continuous computer usage (greater or equal to 50% of the workday) is required Responsibilities
Interfaces with the LRST and AST to lead and support cross-functional company objectives. Lead the GRPT to develop global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seek expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel. 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. Accountable for ensuring that corporate goals are met. 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 regulatory and cross-functional teams in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicate plan to relevant stakeholders. Act independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expand knowledge of TA and provide coaching and mentoring for GRPT members. May have direct report(s) 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 and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements. Ensure alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, present meaningful regulatory assessments and recommendations to executive management. Proactively inform AST and cross functional management of issues, labeling outcomes, approval risks and mitigations. Provide assessment of impact on global programs. Represent ABBV Regulatory position in interactions at Joint Governance. Make decisions regarding work processes or operational plans and schedules to achieve program objectives established by senior management. Advance the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Follow budget allocations and keep supervisor informed on project resourcing. Chairs or sponsors key GRS initiatives and presents 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 a plus. Required Experience: 7+ years regulatory experience with drug development experience in US&C region. Proven 5+ years in strategic leadership with strong project management skills. Experience in a complex, matrix environment with multiple stakeholders and cross-functional influence. Experience interfacing with major government regulatory bodies. Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies. Preferred Experience: 10+ years in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions (US, EU, Japan, etc.). Strong global development foundation with business acumen. Additional Information
Applicable to positions with pay disclosure requirements under state/local law: compensation ranges are described as the range of possible base pay, subject to geographic location and other factors. Individual compensation paid within this range will depend on many factors and may be modified in the future. Benefits include paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. This job is eligible for short-term and long-term incentive programs. AbbVie is an equal opportunity employer. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only – for more information, see AbbVie join-us pages on equal employment opportunity and reasonable accommodations.
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