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The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for the development and implementation of global strategies, ensuring legislation requirements are met. Provides oversight on strategic regulatory decisions and ensures regulatory and cross-functional alignment. Provides oversight of development of impactful strategic messaging in regulatory dossier content. Exercises division and corporate influence, provides expert opinion and leadership to initiatives. When delegated by the TA VP, provides regulatory leadership at the Therapeutic Area Strategy Committee (TASC) to deliver TA strategies, disease state insights, vision and direction to differentiate assets regulatory strategic program risks, regulatory intelligence, and recommendations on portfolio optimization. Has department leadership and budgetary accountabilities

Responsibilities

• Provides leadership and supervision to a team of global regulatory leads (GRLs) who are responsible for developing and implementing regulatory strategy for development and marketed products. Key internal leader and driver of regulatory policy and strategy; ensures development of creative and impactful global product strategies for each product.
• Works to develop and achieve long-range goals and objectives. Determines and pursue courses of action necessary to obtain desired results. Provides guidance to GRL on global regulatory strategies, risk assessments and mitigation strategies. Approves global regulatory product strategies and risk assessments with mitigation plans for products within assigned TAs.
• Supervises GRL personnel. Independently manages product and project assignments within TA, and may participate or lead initiatives. Provides direction and guidance to adjacent regulatory personnel; evaluates performance of and assists in career development planning for other regulatory functions
• Works across TAs for assigned products and influences the development of regulations and guidance
• Advises internal personnel on regulatory strategies. Provides expert assessment on disease state insights, vision, and direction to differentiate assets, regulatory intelligence on global regulatory environment, and provides recommendations to TASC and Sr. Management to optimize portfolio.
• Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures regular regulatory management communication of important timely issues and the impact on the global program and across assigned TA.
• Develops, communicates, and builds consensus for operating goals that are in alignment with the department. Oversees personnel to achieve department objectives. Ensures creation of immediate to long-range plans to carry out objectives established by executive management. Provides guidance and recommendations to direct reports on work processes and operational plan decision-making.
• Advances the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for TA. Represents Regulatory and presents to cross-functional teams as TA Lead. Represents Regulatory on other AbbVie governance and review committees at the request of the TA VP.
• Develops and maintains budget for a department or group to meet organizational goals. Forecasts future departmental needs including human and material resources and capital expenditures. Actively participates in leadership meetings, providing regulatory and management expertise and decision-making. Recommend modifications to the structure of organizational units or a centralized functional activity subject to senior management approval.

Qualifications

• Required Education: Bachelor's degree (pharmacy, biology, chemistry, pharmacology) related life sciences
• Preferred Education: Relevant graduate degree preferred. Certifications a plus
• Experience working in a complex and matrix environment with multiple stakeholders. Proven success bringing products through development review and approval. Broad experience contributing to enterprise management of a portfolio of products. Strong verbal and written communicator with proven negotiation skills and strategic thinking. Strong business acumen and the ability to work under pressure managing a product portfolio
• Strong experience working with multiple functions (Ad/Promo, Labeling, CMC, devices, Clinical development, etc.) and cross functional teams and executive management.
• Proven 10+ years in a strategic leadership role with strong project management skills and demonstrated executive presence.
• 3+ years of supervisory/management experience
• 3 years of supervisory/management experience
• Preferred Experience: 12+ years’ experience in pharmaceutical regulatory activities; preferably with experience as lead regulatory product strategist in at least 2 regions in addition to the US (UK, EU, JAPAC, etc.)
• NOTE: Higher education may compensate for years of experience

This role can work out of multiple office locations: Lake County, IL, Florham Park, NJ, Cambridge, MA

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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 based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This 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. ​

  
  

• This job is eligible to participate in our long-term incentive programs​

  
  

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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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.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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