Associate Director, Regulatory Affairs
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 Associate Director Regulatory Affairs represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of regulatory strategy on R&D project teams. Works with a team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (e.g. US, EU, APAC) with responsibility for working with colleagues on a worldwide basis to support the global strategy. Responsible for content of all regulatory submissions. Acts as primary contact for the US FDA. Directs communications and interactions with US FDA and other regulatory agencies globally as assigned. Ensures technical accuracy and regulatory compliance of all submissions. Ensures that all submissions are made on time. Primary responsibility is in the Neuroscience TA.
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.
- Represent Department on Global Project Team. Develop regulatory strategic plan in consultation with the global regulatory project 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.
- Set strategy for submissions of product registration documents to Health Authorities. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions. Responsible for US submissions (strategy and submission preparation).
- Clearly articulate regulatory strategy at Global Regulatory Project Team meetings. Negotiate with teams to assure acceptance of regulatory strategy. Assure compliance with project team timelines and milestones.
- Effectively plan, organize, and conduct 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.
- Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 6 years’ experience in Regulatory Affairs with successful leadership roles on global project teams; or
- Education equivalent to a MS degree or equivalent in a scientific field, plus at least 8 years’ experience in Regulatory Affairs with successful leadership roles on global project teams; or
- Education equivalent to a BS degree or equivalent in a scientific field, plus at least 10 years’ experience in Regulatory Affairs with successful leadership roles on global project teams;
- Demonstrated excellence in developing global regulatory affairs strategy
- Expert knowledge of US and ICH regulations. Experience with Japanese and Chinese regulations is a significant benefit.
- Ability to travel up to 15%
In this role, we’re looking for a leader who will:
· Act as an Owner
· Be Excellence Focused
· Act as an Influencer
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.