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Research & Development
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186442 Requisition #
Thanks for your interest in the Mgr, Regulatory Affairs position. Unfortunately this position has been closed but you can search our 420 open jobs by clicking here.

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鈥檚 products and operations. Advise personnel in other departments regarding their applicability and impact.

 

 

Preferred Skills/Qualification

       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鈥 experience in Regulatory Affairs; or

       Education equivalent to a MS degree or equivalent in a scientific field, plus at least 4 years鈥 experience in Regulatory Affairs; or

       Education equivalent to a BS degree or equivalent in a scientific field, plus at least 6 years鈥 experience in Regulatory Affairs.

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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