Director, Regulatory Affairs Regulatory Policy & Intelligence
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, Regulatory Policy &
Intelligence, utilizes knowledge of the scientific, regulatory ,
and business environment regarding how medicinal products (and
medical devices where appropriate) are developed, evaluated,
authorized and monitored once marketed to support product
development strategy.. Develops and maintains strong partnership
with regional area and affiliate staff that interact with Health
Authorities (HAs). Monitors external environment for evolving
policies that impact product development and works closely with
Subject Matter Experts (SMEs) to analyze impact and plan strategy
accordingly. Supports development and maintenance of relations with
HAs, peer company and industry trade associations regarding
scientific and regulatory policies. Co-ordinates cross-functional,
multidisciplinary teams, to comment to HAs. Through knowledge
gained, assists company to comply with scientific, ethical,
statutory, quality, and business requirements
Independently manages regional topics in the regulatory policy
and intelligence function. Supports definition of scientific and
regulatory policy initiatives.
May serve as policy subject expert based on in depth knowledge
of key regulatory and scientific issues. Analyzes proposed policies
and distributes to SMEs. Supports development of formation of
corporate position to share with trade associations.
Prepares complex written and oral reports for Senior Management
and external audiences on scientific and regulatory topics.
Proposes sound regulatory policies influencing the regulatory
environment in one or more geographic regions.
Effectively uses negotiation skills to resolve policy issues
when unable to agree internally. Anticipates consequences of path
Serves as liaison to trade associations for management of
scientific and regulatory issues.
Supports supervisor and Senior Management in discussions of
complex policy topics at trade associations.
Contributes to regulatory product development strategy by
responding to information requests and providing an analysis of the
regulatory environment. May offer alternative views based on
regulatory knowledge and prior experience.
Conducts external outreach with regulators, peers and trades.
Responds to opportunities to enhance AbbVie’s relationship by
participating in policy-related meetings. Utilizes local network of
pharma companies to obtain policy-related information.
Required Education: Bachelor’s degree related to health,
environment, or politics. Degrees in Pharmacy, Chemistry, Biology,
Pharmacology, Law or Policy are most relevant.
Preferred Education: Relevant Master’s degree in a scientific,
health, legal or business discipline. Regulatory certifications a
Required Experience: 8+ years in regulated industry or health
authority. Policy and drug development experience is most relevant.
Experience working in complex and matrix environment. Strong
negotiation skills to reach consensus. Strong communication skills,
both oral and written. Fluency in other languages is needed for
Preferred Experience: 3+ years of relevant area experience in
pharmaceutical or other healthcare industry with some regulatory
policy and intelligence experience, specialization in regions or at
trade associations. Regulatory experience is preferred but may
consider backgrounds in quality assurance, research and development
support, scientific affairs, and operations.
Note: Higher education may compensate for years of
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)
Yes, 10 % of the Time
Job Level Code
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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