Allergan Director, Regulatory Affairs in Madison, New Jersey
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 at https://twitter.com/abbvie , Facebook at https://www.facebook.com/AbbVieGlobal , Instagram , YouTube at https://www.youtube.com/user/AbbVie and LinkedIn at https://www.linkedin.com/company/abbvie .
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.
WhatYour 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 tofacilitate success through strong leadership, strategic thinking and personaldrive.
F irst class team player : collaborate across multipledisciplines to ensure compliance and ability to influence cross-functionalteams and senior leadership.
RepresentDepartment at Global Project Team. Develop regulatory strategic plan and provideguidance to project team. Lead GlobalRegulatory Team. Work with team(s) toresolve complex project issues. Utilizeregulatory expertise and knowledge of regulatory requirements and regulationsto strategically interpret, plan, and communicate requirements to ensuregovernmental approvals are obtained.
Set strategy for submissions of product registration documents tohealth authorities worldwide. Interact withother line functions in the preparation, review, and completion of documentsfor regulatory submissions.
Be able to clearly articulate regulatory strategy at GlobalProject and Global Regulatory Team meetings.Also, will be able to negotiate with team to assure acceptance ofregulatory strategy and assurecompliance with project team timelines and milestones.
Effectivelyplan, organize, and conduct (or supervise) formal meetingswith regulatory agencies. Interact withkey personnel in regulatory agencies to ensure the review and approval of developmentplans, the timely resolution of issues, and the approval of marketingapplications.
Provideinterpretive analyses of complex regulatory guidance documents, regulations, ordirectives that impact AbbVie’s products and operations. Advise personnel inother departments regarding their applicability and impact.
Bachelors degreerequired. Advanced degree preferred.
10-15 years’ regulatoryaffairs experience.
Experience directlyinterfacing with US and EU regulatory bodies.
Abilityto travel up to 20% (domestic and international)
In this role, we’re looking fora 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.