Allergan
Director, Global Regulatory Lead (Oncology)
Allergan, Waltham, Massachusetts, United States, 02254
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 products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
www.abbvie.com . Follow @abbvie on
Twitter ,
Facebook ,
Instagram ,
YouTube
and
LinkedIn .Job Description
The Director Regulatory Affairs Global Regulatory Lead, 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. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies.Interfaces with the LRST and AST to lead and support cross-functional company objectives.Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.Leads 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.Leads preparation of global regulatory product strategies for assigned products.Acts independently under the direction of a GRS Sr GRL or TA Head.Influences the development of regulations and guidance.Follows company policies and procedures for regulatory record keeping.Ensures alignment of global regulatory strategies with Sr. Management.Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.Follows budget allocations and keeps supervisor informed on project resourcing.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. Some portion may include experience related to pharmaceutical regulatory work.Required Experience cont'd: Strong communication and proactive negotiation skills.Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities.Note: Higher education may compensate for years of experience.This position can be located in Lake County, IL, Waltham, MA, or South San Francisco, CA.Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting.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.This job is eligible to participate in our long-term incentive programs.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
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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 products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
www.abbvie.com . Follow @abbvie on
Twitter ,
Facebook ,
Instagram ,
YouTube
and
LinkedIn .Job Description
The Director Regulatory Affairs Global Regulatory Lead, 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. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies.Interfaces with the LRST and AST to lead and support cross-functional company objectives.Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.Leads 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.Leads preparation of global regulatory product strategies for assigned products.Acts independently under the direction of a GRS Sr GRL or TA Head.Influences the development of regulations and guidance.Follows company policies and procedures for regulatory record keeping.Ensures alignment of global regulatory strategies with Sr. Management.Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.Follows budget allocations and keeps supervisor informed on project resourcing.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. Some portion may include experience related to pharmaceutical regulatory work.Required Experience cont'd: Strong communication and proactive negotiation skills.Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities.Note: Higher education may compensate for years of experience.This position can be located in Lake County, IL, Waltham, MA, or South San Francisco, CA.Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting.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.This job is eligible to participate in our long-term incentive programs.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
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