Director, Regulatory Affairs

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 .

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

The Director, Regulatory Affairs is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. He/She will communicate regulatory strategy to project teams developing pharmaceutical/biologic/combination products. Leading a 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 and directing communications and interactions with US FDA and other regulatory agencies worldwide. You will be responsible for covering multiple development projects.

YOU ARE more than just a title, YOU ARE...

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. Develops regulatory strategic plan and provide guidance to project team. Lead Global Regulatory Team. Work with team 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. Manage and mentor direct report(s), where line management responsibilities exist.
• 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.
• 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. Ensure 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 affect AbbVie's products and operations. Advise personnel in other departments regarding their applicability and effect.

#LI-PD1

Qualifications

You Bring

• PhD, PharmD or MD degree or equivalent in a scientific field, plus at least 8 years' experience in Regulatory Affairs with successful leadership roles on global project teams.
• MS degree or equivalent in a scientific field, plus at least 10 years' experience in Regulatory Affairs with successful leadership roles on global project teams
• BS degree or equivalent in a scientific field, plus at least 12 years' experience in Regulatory Affairs with successful leadership roles on global project teams
• Demonstrated excellence in developing global regulatory affairs strategy for tissue products and other medical devices.
• Ability to travel
• Demonstrated excellence in developing global regulatory affairs strategy for tissue products and other medical devices.

In this role, we're looking for a leader who will :

• Act as an Owner
• Be Excellence Focused
• Act as an Influencer

Travel
Yes, 10 % of the Time

Job Type
Standard

Schedule
Full-time

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.