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Associate Director, Regulatory Affairs

Company: AbbVie, Inc.
Location: Madison
Posted on: September 12, 2020

Job Description:

Job Description 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 withenergetic colleagues and inspirational leaders. Now, place yourself in thatmix; leading discussions, asking the right questions and driving results.

WhatYour New Manager Wants You To Know

The Associate Director Regulatory Affairs represents Regulatory Affairs for pharmaceuticaldevelopment projects and marketed products. Responsible for development andcommunication of all aspects of regulatory strategy on R&D projectteams. Works with a team of regulatory professionals to assure successfulplanning 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 basisto support the global strategy. Responsible for content of all regulatorysubmissions. Acts as primary contact for the US FDA. Directscommunications and interactions with US FDA and other regulatory agencies globallyas assigned. Ensures technical accuracy and regulatory compliance of allsubmissions. Ensures that all submissions are made on time. Primaryresponsibility is in the Neuroscience TA.

YOU ARE more than just a title, YOU ARE…

Firstclass team player : collaborateacross multiple disciplines to ensure compliance and ability to influencecross-functional teams and senior leadership.

You Will

Represent Department on Global ProjectTeam. Develop regulatory strategic plan in consultation with the globalregulatory project team. Work with team to resolve complex projectissues. Utilize regulatory expertise and knowledge of regulatoryrequirements and regulations to strategically interpret, plan, and communicaterequirements to ensure governmental approvals are obtained.

Set strategy for submissions of productregistration documents to Health Authorities. Interact with other linefunctions in the preparation, review, and completion of documents forregulatory submissions. Responsible for US submissions (strategyand submission preparation).

Clearly articulate regulatory strategy at GlobalRegulatory Project Team meetings. Negotiate with teams to assureacceptance of regulatory strategy. Assure compliance with project teamtimelines and milestones.

Effectively plan, organize, and conduct formalmeetings with regulatory agencies. Interact with key personnel inregulatory agencies to ensure the review and approval of development plans, thetimely resolution of issues, and the approval of marketing applications.

Provide interpretive analyses of complexregulatory guidance documents, regulations, or directives that impact Abbvie’sproducts and operations. Advise personnel in other departments regarding theirapplicability and impact.



You Bring

Education equivalent to a PhD or MDdegree or equivalent in a scientific field, plus at least 6 years’ experiencein Regulatory Affairs with successful leadership roles on global project teams;or

Educationequivalent to a MS degree or equivalent in a scientific field, plus at least8 years’ experience in Regulatory Affairs with successful leadership roleson global project teams; or

Educationequivalent to a BS degree or equivalent in a scientific field, plus at least10 years’ experience in Regulatory Affairs with successful leadershiproles on global project teams;

Demonstrated excellence in developing globalregulatory 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 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.

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Keywords: AbbVie, Inc., Madison , Associate Director, Regulatory Affairs, Other , Madison, Wisconsin

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