Sr. Manager, 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 .

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

The Sr. Manager Regulatory Affairs represents US Regulatory Affairs for pharmaceutical development projects and marketed products. You will be responsible for development and communication of global regulatory strategy on R&D project teams. Ensure technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted on time. Has authority to make decisions on US regulatory strategy and to submit complex submissions. Directs communications and interactions with US FDA and other regulatory agencies as needed. Acts as primary contact for the US FDA. Supports management with development of, and as appropriate, leads implementation of department strategies and policies.

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 . Develop US regulatory strategic plan and provides guidance to GRL and project team. Represent US Regulatory on Global Regulatory Teams for assigned development projects and marketed products. Work with GRL/manager to resolve complex project issues. Utilize US regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
• Work with manager, s et strategy for submissions of product registration documents to health authorities worldwide . Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions. Responsible for US submissions (strategy and submission preparation).
• Be able to clearly articulate US regulatory strategy at Project and Regulatory Team meetings. Able to negotiate with team to assure acceptance of regulatory strategy. Assures compliance with project team timelines and milestones.
• Work with manager, 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. Act as primary contact for the US FDA.
• 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.

#LI-PD1

Qualifications

You Bring

• Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 4 years' experience in Regulatory Affairs; or
• Education equivalent to a MS degree or equivalent in a scientific field, plus at least 6 years' experience in Regulatory Affairs; or
• Education equivalent to a BS degree or equivalent in a scientific field, plus at least 8 years' experience in Regulatory Affairs;
• Working knowledge of EDMS systems for electronic storage and submission.
• Advanced knowledge of US and ICH regulations

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.