Deputy Director, Regulatory In Whippany in Manhattan, New York For Sale
Company Description
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Job Description
Deputy Director, Regulatory In Whippany
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Job Description:
Divisions include
Specialty Pharmaceuticals, Medical Care, Consumer Care and Animal Health. At this top tier Pharma company you have the opportunity to be part of a culture where they value the passion of their
employees to innovate and give them the power to change.
The company is expanding and looking for a DEPUTY DIRECTOR , REGULATORY for their Class III /PMA /Medical Device High Profile Trials
Must have Medical Device experience within the Pharma/Biotech/Device industries.
Responsibilities:
Acts as the primary interface between Company and the Health Authority.
May assume global Lead GRS role and may represent GRA on GPT or represents a region in close cooperation with the Lead GRS
Participates on and may lead a global regulatory team (GRT)
Contribute to global regulatory strategy and project goals for assigned projects from development through life cycle management.
May lead the development of the global regulatory strategy and project goals for assigned projects from development through life cycle.
Actively involved in decision making on all key development questions
Organizes and drives preparations for meetings and teleconferences with local HA officials
Compile and submit regulatory filings including: IDEs, IDE amendments, clinical trial applications, PMAs, PMAS, Design Dossiers, etc.
Develop submission materials for local HA, guides the review process, checks for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission
Collects, reviews and analyzes local and global Agency guidelinesand precedence, as well as competitor information, in order to provide advice to project team
Provides guidance to other functions / staff to assure clinical trial programs are carried out in accordance with all regulations
Provide regulatory risk assessment for project on a local basis and global level
Co-ordinates regulatory matters with license partners.
Advanced technical degree Ph.D., DVM or Pharm D in life sciences or engineering preferred 8 years in medical device industry of which a minimum of 3 years include local/ global regulatory experience, or
MS degree with 10 years of medical device activities of which a minimum of 5 years include local/global regulatory experience
The incumbent must have expertise in regional and local regulations as well as a working knowledge of global regulations as well as demonstrated interactions with local and global health authorities.
Expert knowledge of medical devices and proven track record for products of this class.
Demonstrated knowledge of adverse event reporting requirements is also required.
Excellent communication skills, verbal and written, are required.
The ability to work within a global team framework and a multi-cultural environment is required.
Strong analytical skills are necessary to interpret regulatory data and make critical decisions. The incumbent will be required to focus on multiple issues at one time, and must have the ability to organize.
Demonstrated leadership and project management skills.
Preferred qualifications:
In-depth knowledge, domestic and global, of clinical trial methodology.
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