Manager Regulatory Affairs

Edison, NJ

Posted: 04/09/2019 Industry: Laboratory - Food & Beverage Job Number: 156.19JF Pay Rate: 150,000 - 170,000

Manager Regulatory Affairs

The Associate Manager / Manager of Regulatory Affairs supports the Oral Care Technology function in the maintenance of existing oral care products and the development of new oral care products for the U.S. market.  This support includes managing all regulatory activities necessary to maintain and to grow the U.S. Oral Care franchise.  This position is responsible for developing and implementing regulatory strategies for new and existing products regulated under the IND/NDA/ANDA, Medical Device 510(k), OTC Monograph and Cosmetic designations.

This position may also have some responsibility for Personal Care and Home Care products and may be responsible for other assigned products and projects.  The position will serve as a resource to Technology, the U.S. Division and Supply Chain, to ensure alignment with Business, Supply Chain and Technology objectives, programs, strategies, policies and procedures.

Responsibilities:

  • Represent and strengthen the expertise in regulatory processes and procedures, using business knowledge to develop actionable regulatory and registration strategies
  • Support Global Technology innovation platforms for existing and new products.
  • Communicate the impact of changes in the regulatory environment to the Business and modify strategies accordingly
  • Collaborate with internal partners and stakeholders on regulatory procedures, requirements and potential barriers, and work accordingly to incorporate them into the Technology and Business plans and programs
  • Establish strong relationships with Corporate and Regional Technology Partners, and with the Divisional stakeholders such as Marketing, Legal, Technical, Supply Chain, Regulatory and Product Safety, to ensure tight alignment and synchronization among Regulatory strategies, product development and business goals
  • Maintain Regulatory filings and Health Authority communications through electronic and paper records in a timely, accurate and efficient manner
  • Provide Regulatory guidance and advice to R&D and other stakeholders
  • Stay abreast of current and new U.S. Drug, Device and Cosmetic regulations and guidelines, and ensure adherence throughout product lifecycle
  • Ensure productive and collaborative working relationships with the U.S. FDA and other government authorities. Provide category support on day-to-day regulatory issues, new initiatives and developments
  • Represent company to trade associations as assigned, and provide clear updates to stakeholders as necessary

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Jeff Fee at jfee@cps4jobs.com.

JO:  156.19JF
#LI-JF1

Requirements:

  • Bachelor’s Degree with a minimum of 10 years of regulatory experience required
  • Master’s degree highly preferred
  • Working knowledge of U.S. regulatory requirements for INDs and NDAs preferred; experience with eCTD and drug product registration ex-U.S. will be considered
  • Strong interpersonal and relationship-building abilities
  • Effective communication and presentation skills
  • Robust experience with management of multidisciplinary projects to RA department systems and processes
  • Ability to successfully juggle multiple competing priorities while maintaining attention to detail

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Jeff Fee at jfee@cps4jobs.com.

JO:  156.19JF
#LI-JF1

 

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