For The Candidates
RA Senior Director - Regulatory Affairs - Clinical/Strategy- Pharm
Nj
Type:
Full-Time
Category:
Regulatory Affairs
Job ID:
811
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Opportunity Description:
( 908) Area code Central New Jersey
Senior Director, Global Regulatory Affairs |
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| The Senior Director, Global Regulatory Affairs develops regulatory strategies, filing necessary applications and handling government interactions pertaining to the regulation process for products requiring governmental approval |
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12 years regulatory affairs experience in the pharmaceutical industry, most recently in drug regulatory affairs
Principal Responsibilities and Duties:
Interpret and apply applicable laws, regulations and guidelines governing drugs and devices to meet business objectives.
Develop regulatory strategies, in conjunction with business objectives, and translate plans into operational deliverables (i.e. submissions); advise company on regulatory issues concerning products and operations; manage regulatory activities in respect to quality and timeliness.
Interacts with health authorities, including inspections at the central New Jersey facilities, and oversee the preparation for meetings with health authorities.
Assure timely continuity of company product registrations renewals.
Partner with internal departments of the company to assure development plans align with regulatory requirements and guidelines; interact with other disciplines to review and finalize reports and other documents.
Participate on project teams and serve as an advisor with regard to Regulatory Affairs issues and procedures.
Develop policies and procedures to ensure regulatory compliance; manage direct reports and provide opportunities for professional development; manage regulatory consultants as required; may review and provide assessment of potential licensing acquisitions relative to regulatory implications and limitations; may participate in company advisory boards, attend congress and professional meetings, and be a company spokesperson
Knowledge: Familiar with a variety of pharmaceutical concepts, practices, and procedures including: 21 CFR 50,54,56,200,201,202,207,312,314, and ICH.
Skills: Strategic and operational skills in reading and interpreting applicable laws; strong organizational skills; excellent written and verbal communication, negotiation/persuasion, and interpersonal skills; detailed oriented.
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