Director, Global Regulatory Affairs - Aesthetics
Posted on: May 18, 2023
At Allergan Aesthetics, an AbbVie company, we develop,
manufacture, and market a portfolio of leading aesthetics brands
and products. Our aesthetics portfolio includes facial injectables,
body contouring, plastics, skin care, and more. Our goal is to
consistently provide our customers with innovation, education,
exceptional service, and a commitment to excellence, all with a
personal touch. For more information, visit
www.AllerganAesthetics.com. Director, Global Regulatory Affairs -
Aesthetics Primary Irvine, California Req ID 2210683 Category
Regulatory Affairs Division Allergan Aesthetics TheDirector
Regulatory Affairs is independently responsible for development of
global regulatory strategy and representation of Regulatory Affairs
on R&D project teams. Communicates regulatory strategy to
project teams developing pharmaceutical or medical device Leads
team of regulatory professionals to ensure successful planning and
completion of regulatory activities on a worldwide basis.
Responsible for knowledge of regulatory requirements of major
regions (US, EU, Japan and China) with responsibility for working
with colleagues on a worldwide basis to form a global strategy.
Responsible for content of global regulatory submissions. Directs
communications and interactions with US FDA and other regulatory
agencies worldwide. Responsible for covering multiple development
- Advisory Responsibilities: Represents Department at Global
Project Team. Develops regulatory strategic plan and provides
guidance to project team. Leads Global Regulatory Team. Works with
team to resolve complex project issues. Utilizes regulatory
expertise and knowledge of regulatory requirements and regulations
to strategically interpret, plan, and communicate requirements to
ensure governmental approvals are obtained. Manage and mentor
direct report(s), where line management responsibilities exist.
- Submissions: Sets strategy for submissions of product
registration documents to health authorities worldwide. Interacts
with other line functions in the preparation, review, and
completion of documents for regulatory submissions.
- Communications: Able to clearly articulate regulatory strategy
at Project Team and Global Regulatory Team meetings. Able to
negotiate with teams to ensure acceptance of regulatory strategy.
Ensures compliance with project team timelines and milestones.
- Health Authority Interactions: Effectively plan, organize, and
conduct (or supervise) formal meetingswith regulatory agencies.
Interact with key personnel in regulatory agencies to ensure the
review and approval of development plans, the timely resolution of
issues, and the approval of marketing applications.
- Regulatory Compliance: Provide interpretive analyses of complex
regulatory guidance documents, regulations, or directives that
affect Allergan's products and operations. Advise personnel in
other departments regarding their applicability and effect.
- 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: 5+ years of regulatory experience. Some
portion may include relevant exposure to pharmaceutical or medical
device regulatory work (e.g., other R&D role or specialized
- Requires drug development experience in US and Canadaregion.
Proven 3-5 years in a leadership role with strong management
- Experience working in a complex and matrix environment, and
with multiple stakeholders.
- Experience interfacing with government regulatory
- Experience working with Health Authority Strong communication
and proactive negotiation skills. Business acumen and able to work
under pressure Preferred Experience: 7+ years' experience in
pharmaceutical regulatory activities; preferably in at least 2
- Experience developing and implementing successful global
regulatory strategies. Strong clinical foundation preferred. Note:
Higher education may compensate for years of experience Applicable
to California Applicants Only
- The below range is the range that we in good faith believe is
the range of possible compensation for this role at the time of
this posting. We may ultimately pay more or less than the posted
range and this range is only applicable for jobs to be performed in
California. This range may be modified in the future.
- The salary range is (minimum: _$146,000__ to
- This job is eligible to participate in our short-term incentive
- This job is eligible to participate in our long-term incentive
- We offer comprehensive package of benefits including paid time
off (vacation, holidays, sick), medical/dental/vision insurance and
401(k) to eligible employees.
- 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
discretion unless and until paid and may be modified at the
Company's sole discretion, consistent with the law. At AbbVie, we
value bringing together individuals from diverse backgrounds to
develop new and innovative solutions for patients. As an equal
opportunity and affirmative action employer, we do not discriminate
on the basis 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, protected veteran status, or
any other legally protected characteristic. If you would like to
view a copy of the company's affirmative action plan or policy
statement, please email CorpJat_ABV@abbvie.com .Explore our open
jobs and find your perfect fit.Join our talent network and receive
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Phone number Email address Interested In Please select a category
or location option. Click "Add" to create your job alert. Category
- Regulatory Affairs, Irvine, California, United States Remove
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Keywords: Allergan, Irvine , Director, Global Regulatory Affairs - Aesthetics, Executive , Irvine, California
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