Manager, Regulatory Affairs

The Manager will represent Regulatory Affairs for pharmaceutical development projects and marketed products. Working with manager, responsible for development and communication of global regulatory strategy on R&D project teams. 

The Manager Regulatory Affairs will 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 regulatory strategy and to submit complex submissions. Directs communications and interactions with US FDA and other regulatory agencies worldwide.  Acts as primary contact for the US FDA. Supports management with development of, and as appropriate, leads implementation of department strategies and policies. 

Advisory Responsibilities:

Represents Department at Global Project Team.  Develops regulatory strategic plan and provides guidance to project team.  Leads Global Regulatory Team for assigned development projects and marketed products.  Works with manager to resolve complex project issues.  Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.

Project Execution:

Working with manager, sets 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).

Communications:

Able to clearly articulate regulatory strategy at Global Project and Global Regulatory Team meetings.  Able to negotiate with team to assure acceptance of regulatory strategy.  Assures compliance with project team timelines and milestones.

Health Authority Interactions:

Working 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. Acts as primary contact for the US FDA. 

Regulatory Compliance:

Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact Allergan’s products and operations. Advise personnel in other departments regarding their applicability and impact.

 

Preferred Skills/Qualifications

• Analytical thinking and problem-solving skills.
• Excellent communication skills, verbal and written.
• Excellent interpersonal skills and leadership potential.
• Computer literate with knowledge of EDMS systems for electronic storage and submission.
• Advanced knowledge of US and ICH regulations.
• Excellent negotiation skills.
• Ability to influence without authority.

Education

• Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 2 years’ experience in Regulatory Affairs; or
• Education equivalent to a MS degree or equivalent in a scientific field, plus at least 4 years’ experience in Regulatory Affairs; or
• Education equivalent to a BS degree or equivalent in a scientific field, plus at least 6 years’ experience in Regulatory Affairs.

 

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

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

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

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

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 and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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.