AbbVie

Director, Regulatory Affairs Regulatory Policy & Intelligence

Employer
AbbVie
Location
Rockville, MD, United States
Posted
Sep 10, 2020
Ref
2004332
Required Education
Bachelors Degree
Position Type
Full time
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

Responsibilities
  • 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 chosen.
  • 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.


Qualifications

  • 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 plus.
  • 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 regional assignments.
  • 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 experience


Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % 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.