Director, RA Global Regulatory Strategy
Company: AbbVie, Inc.
Location: Clearlake
Posted on: February 22, 2021
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Job Description:
Job Description About AbbVie
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 .
The Director Regulatory Affairs Global Regulatory Lead,--Global
Regulatory Strategy, is responsible for developing and implementing
global, US and Canadian regulatory strategies to secure and
maintain market approval in the assigned therapeutic area. Leads
the Global Regulatory Product Team (GRPT), expands TA knowledge,
and manages strategic messaging and content of global, US and
Canadian regulatory dossiers. Serves as the primary regulatory
interface with ADT and supporting teams. Proactively anticipates
and mitigates regulatory risks. Ensures compliance with global
regulatory requirements. Demonstrates understanding of drug
development and leadership behaviors consistent with level.
Develops and implements acceleration strategies. Ensures alignment
of global regulatory strategies with Sr. management. May have
direct reports.
Qualifications
Bachelor's degree in life sciences (pharmacy, biology, chemistry,
pharmacology) or related subject.
Relevant advanced degree is preferred. Certification a plus.
7+ years regulatory experience. Some portion may include experience
related to pharmaceutical regulatory work (e.g., other R&D role
or specialized training). Requires drug development experience in
US&C region.
Proven 3-5 years in a leadership role with strong management
skills.
Experience working in a complex and matrix environment with
multiple stakeholders and on cross-functional teams.
Strong communication and proactive negotiation skills. Experience
contributing to enterprise management of a portfolio of
products.
Experience interfacing with government regulatory agencies.
Experience developing and implementing successful global regulatory
strategies.
10 years' experience in pharmaceutical regulatory activities;
preferably with experience as lead regulatory product strategist in
two or more major regions such as EU or Japan.
Strong clinical foundation preferred with business acumen.
Note: Higher education may compensate for years of experience.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive
hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients.
As an equal opportunity 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.
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Keywords: AbbVie, Inc., Santa Rosa , Director, RA Global Regulatory Strategy, Executive , Clearlake, California
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