Director, Regulatory Affairs

Irvine, CA, United States
Oct 17, 2020
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 . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

In this new and exciting position, the Director, Regulatory Affairs will independently be responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. As a Director, you will communicate regulatory strategy to global project teams developing pharmaceutical products. You will be the lead for the team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Also, the Director will have a thorough understanding of regulatory requirements of major regions with the responsibility for working with colleagues on a worldwide basis to form a global strategy. You will be responsible for content of global regulatory submissions as well as directing communications and interactions with US FDA and other regulatory agencies worldwide. You will have responsibility to work in one or more therapeutic areas, covering multiple development projects.

YOU ARE more than just a title, YOU ARE...
  • A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.
  • First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will
  • Represent Department at Global Project Team . Develop regulatory strategic plan and provide guidance to project team. Lead Global Regulatory Team. Work with team(s) to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
  • Set strategy for submissions of product registration documents to health authorities worldwide . Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions.
  • B e able to clearly articulate regulatory strategy at Project team and Global Regulatory Team meetings. Also, will be able to negotiate with team to assure acceptance of regulatory strategy and a ssure compliance with project team timelines and milestones.
  • Effectively plan, organize, and conduct (or supervise) formal meetings with 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.
  • Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact AbbVie's products and operations. Advise personnel in other departments regarding their applicability and impact.


You Bring
  • Bachelors degree required. Advanced degree preferred.
  • 10-15 years' regulatory affairs experience.
  • Experience directly interfacing with US and EU regulatory bodies.
  • Ability to travel up to 20% (domestic and international)

In this role, we're looking for a leader who will :
  • Act as an Owner
  • Be Excellence Focused
  • Act as an Influencer

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.