07 October 2021
Associate Director of Regulatory Affairs

Title:  Associate Director North America Regulatory Affairs (Medical device & new drug introduction).
Locations:  New Jersey
Remote:  No 
 
The Experience
Our client, is a Fortune 500 company and a leader in the Consumer Product Group industry, is looking for an Associate Director North America Regulation Affairs executive (Medical device & new drug introduction).
 
In today’s dynamic environment, it is an exciting time to be a part of the research and technology team. Our highly technical and innovative team is dedicated to driving growth for our company in this ever-changing landscape.
 
What role will you play as a member of the Research & Development team?
 
  • As the Associate Director North America Regulatory Affairs, you will be responsible to support the Oral Care and Toothbrush Technology functions in the maintenance of existing products and the development of new products for the U.S. and Canadian markets. This includes providing strategic regulatory mentorship and leading all regulatory activities vital to maintain and to grow the North American professional Oral Care franchise.
  • The Associate Director of Regulatory Affairs applies regulatory intelligence and expertise to effect innovative regulatory pathways and solutions for sophisticated regulatory requirements to support Company’s products with IND/NDA/ANDA/DIN and Medical Device designations.
  • This position also has responsibility for other new drug submissions, such as surface disinfectants and antiseptic skin cleansers. The position will serve as a resource to Technology, the North America Division and Supply Chain to ensure alignment with shared objectives, programs, strategies, policies and procedures. This position has one direct report in the United States and works closely with Canadian Regulatory to resolve whether regulatory approval is required and to align on submission strategy.
 
Who are you?
You are a leader:
  • Serves as liaison and chief correspondent to USFDA and Health Canada on all drug and device pre-submission meetings and lifecycle submissions.
  • Subject matter authority in regulatory processes and procedures for drugs and devices, including IND/NDA/ANDA/NDS/DIN/510k pathways.
  • Uses business and regulatory knowledge to provide mentorship and support to Global Technology partners.
  • Leads cross-functional teams to build and implement intelligent regulatory strategies throughout the product lifecycle.
  • Plans and supervises regulatory submissions and all post-marketing commitments to FDA and Health Canada to assure quality, compliance and timeliness.
  • Leads planning and execution of device submissions to USFDA, including Medical Device 510K Notifications, de novo Submissions, Pre-Market Approvals (PMAs) as needed.
  • Monitors and interprets changes to U.S., Canadian, ICH and ISO guidances and regulations governing product development, testing, manufacture, labeling, advertising and promotion.
  • Reviews manufacturing/quality change controls to assess the scope/impact of the change(s) and to recommend the appropriate regulatory pathway to implement the change(s).
 
Requirements:
  • Bachelor's Degree and minimum 15 years of experience of confirmed ability showing progression through roles of growing responsibility.
  • Experience with device or drug applications to the U.S. FDA
 
Preferred:
  • Direct, recent experience in the new drug approval process and handling face-to-face meetings with Health Authorities. U.S. FDA experience with INDs and NDAs for nonprescription drugs.
  • Confirmed knowledge of ICH requirements plus hands-on experience with EMA, Health Canada or TGA medicine approval will be considered.
  • Direct experience participating in pre-submission meetings with regulatory agencies.
  • Knowledge of U.S. medical device clearance requirements and familiarity with ISO standards.