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AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Vice President - Global Regulatory Affairs, Aesthetics

Irvine, California Req ID 2208545 Category Regulatory Affairs Division AbbVie

The Vice President, Global Regulatory Affairs Strategy - Aesthetics provides oversight for the development and implementation of medical device strategies, ensuring legislation requirements are met.  In this critical organizational leadership role, The VP will provide regulatory expertise and guidance for the development, registration and lifecycle management of our Aesthetics programs, which includes both pharmaceutical and medical device programs.  He/She will make strategic regulatory decisions, advise on regulatory strategies and pathways, ensuring regulatory and cross-functional alignment.  The incumbent functions as a company expert and provides guidance and leadership for all Regulatory activities within Aesthetics portfolio and marketed products, in strong cross functional partnership with other AbbVie business units.

 

Reporting directly to the SVP & Head of Aesthetics R&D, this role exercises division and corporate influence, provides expert opinion, and leadership to initiatives. Provides regulatory leadership at the R&D Aesthetics Leadership Team to deliver Aesthetics Therapeutic Area strategies, disease state insights, vision, and direction to differentiate assets, regulatory strategic program risks, regulatory intelligence, and recommendations on portfolio optimization.    The incumbent is also responsible to support & drive thoughtful and thorough organizational development for the regulatory team members.

 

Responsibilities:

  • Key internal leader and driver of regulatory policy and strategy; ensures completion of strategies for each product.
  • Has responsibility for maintaining relations with all Regulatory Agencies.  Heavy interface with the US FDA and is responsible for all interactions and submissions with the US FDA for Aesthetics activities
  • Works to obtain long-range goals and objectives. Determines and pursues course of action necessary to obtain desired results. Provides guidance to GRL on regulatory strategies, risk assessments and mitigation strategies. Approves regulatory product strategies and risk assessments with mitigation plans for products within assigned TA.
  • Leads GRLs. Manages product and project assignments within TA and may participate or lead initiatives.
  • Works across assets for assigned products and influences the development of regulations and guidance.
  • Ensures management is advised of the effect of current, newly finalized, or proposed laws, regulations, guidelines and standards, advisory committee recommendations within assigned TA.
  • Advises on regulatory strategies. Provides expert assessment on disease state insights, vision, and direction to differentiate assets, regulatory intelligence on regulatory environment and provides recommendations to ELT to optimize portfolio.
  • Proactively drives alignment with 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.
  • Provides executive management with meaningful regulatory measurements and regulatory opinion.
  • Develop, communicate, and build consensus for operating goals that are in alignment with the division.
  • Oversees personnel to achieve department objectives. Ensures creation of immediate to long-range plans to carry out objectives established by executive management.
  • Advances the organization’s goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate for TA.
  • Represents Regulatory on appropriate governance and review committees.
  • 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.
Qualifications:

Requirements

  • Bachelor’s Degree in science required at a minimum (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy)
  • Relevant Master’s or Ph. D, or advanced scientific or law degree preferred
  • RAC Certification preferred
  • 15+ years experience, with ideally 12 of them within Regulatory Affairs, with strong Experience with global organizations and medical devices is highly preferred.
  • Experience developing and driving strategy for commercialization and post-marketing activities and requirements for approved products in major markets, such as North America, EMEA, Japan, China is preferred
  • Proven 10+ years in a leadership role with direct management experience preferred
    • Strong leadership and management skills – track record of building high-performing teams. Can effectively hire talent, retain talent, set expectations, coach and top-grade the organization where appropriate
    • Experience building effective relationships across boundaries while working in a complex and matrix environment
  • Ability to travel up to 15-20%, domestically and internationally

 

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 15 % of the Time
Job Type: Experienced
Schedule: Full-time
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