Director, Regulatory Affairs, Strategic Global Labeling

The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). Collects and analyzes labeling issues and trends that affect the business. Possesses and leverages solid understanding of labeling regulations, opinions and guidances of regulatory authorities, political and legal climate and industry practices to ensure that organizational goals are met. Operates independently with recognition of when to consult upper management concerning potential risk. Establishes labeling policy compliant with changing regulatory environment. Manages labeling staff for assigned therapeutic area(s).

Responsibilities

• Develops and directs regulatory labeling strategy planning for or across assigned product group and ensures labeling strategies are in-line with business needs. Presents process, strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings (Global Regulatory Forum (GRF), Executive Labeling Committee (ELC), Steering Committee)
• Leads cross functional labeling teams including regulatory, clinical and safety. Manages labeling history and negotiation documentation for assigned products. Provides labeling strategy and direction to teams involved in agency activities. Leads resolution for labeling issues
• Ensures that agreed regulatory strategies or commercial concepts are efficiently implemented in labeling documents, and that labeling strategies are maintained in-line with changing regulatory and business needs. Ensures labeling documents meet R&D and commercial needs
• Develops and implements internal and/or external strategies to proactively influence legislation/ guidelines with impact on AbbVie business, and to address changes in the regulatory environment. Represent company with regulatory agencies on labeling policy topics. May represent company at inspection activities for labeling topics
• Ensures standard interpretation of regulations across projects.
• Develops and manages an effective team. Conducts succession planning. Manages the work of direct reports. Trains new personnel and provides input to new department processes/policies
• Represents company at external labeling meetings with partner companies or industry associations

Requirements

Qualifications

• Required Education: Bachelor’s Degree in Pharmacy, Biology, Chemistry or Microbiology
• Preferred Education: Relevant Master’s degree preferred. Certification in regulatory affairs a plus
• Required Experience: 10+ years pharmaceutical, regulatory or industry related experience. 8 years in pharmaceutical experience. Proven 3-5 years in a leadership role
• Experience working in a complex and matrix environment
• Strong communication skills, both oral and written
• Strong management skills and multi-disciplinary team management
• Experience working with Health Authority
• Note: Higher education may compensate for years of experience

This role can sit out of Lake County, IL, Florham Park, NJ, or Irvine, CA.

Additional information

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.

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