Vice President - Global Regulatory Affairs, Aesthetics
Location: Los Angeles
Posted on: June 26, 2022
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,
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Vice President - Global Regulatory Affairs, Aesthetics Irvine,
California Req ID 2208545 Category Regulatory Affairs Division
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
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.
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
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
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
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.
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
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
Significant Work Activities: Continuous sitting for prolonged
periods (more than 2 consecutive hours in an 8 hour day) Explore
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Keywords: Allergan, Los Angeles , Vice President - Global Regulatory Affairs, Aesthetics, Executive , Los Angeles, California
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