Senior Manager RA, Global Regulatory Strategy

The Sr. Manager Regulatory Affairs represents US Regulatory Affairs for Body Contouring development projects and marketed medical devices. Working with manager, responsible for development and communication of global regulatory strategy on R&D project teams.

Ensures 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 and supports interactions with our Notified Body. Supports management with development of, and as appropriate, leads implementation of department
strategies and policies.

Responsibilities:

• 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, 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. Will be responsible for US submissions (strategy and submission preparation). 
• Will clearly articulate US regulatory strategy at Project and Regulatory Team meetings. Be able to negotiate with team to assure acceptance of regulatory strategy. Assures compliance with project team timelines and milestones.
• Will clearly articulate US regulatory strategy at Project and Regulatory Team meetings. Be able to negotiate with team to assure acceptance of regulatory strategy. Assures compliance with project team timelines and milestones.
• Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact Allergan Aesthetics’ 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 or experience in lieu of, plus at least 4 years’ experience in Regulatory Affairs; or
• Education equivalent to a MS degree or equivalent in a scientific field or experience in lieu of, plus at least 6 years’ experience in Regulatory Affairs; or
• Education equivalent to a BS degree or equivalent in a scientific field or experience in lieu of, plus at least 8 years’ experience in Regulatory Affairs;
• Analytical thinking and problem-solving skills
• Ability to manage a budget and forecast financial requirements 
• Excellent communication skills, verbal and written.
• Prior US medical Device submission (e.g. 510 (k), PMA) and change assessment experience. 
• Familiarity with ISO 13485 and advanced knowledge of US regulations. EU experience with MDD (Council Directive 93/42/EEC) and MDR (Regulation EU 2017/745) preferred. 
• Excellent interpersonal skills and leadership potential.
• Strong understanding of scientific principles and clinical outcome analysis. 
• Computer literate with knowledge of EDMS systems for electronic storage and submission.
• Excellent negotiation skills

Applicable to California Applicants Only 

The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future. 

The salary range for this role is posted below 

This job is eligible to participate in our short-term incentive program 

This job is eligible to participate in our long-term incentive programs 

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.