Regulatory & Clinical Affairs Specialist in Princeton, New Jersey | DiversityInc Careers
 
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Regulatory & Clinical Affairs Specialist


Johnson & Johnson Group of Consumer Companies is recruiting a Regulatory & Clinical Affairs Specialist for NeoStrata be located in Princeton, NJ. 

 

NeoStrata Company, Inc., a global leader in Specialty Beauty with professionally-endorsed brands including NeoStrata®, Exuviance® and CoverBlend® develops and markets innovative antiaging skincare products incorporating the Company’s propriety ingredient technologies including patented bionic acids, Aminofil®, and N-acetyl glucosamine.

  The person will have responsibility for executing multiple regulatory and clinical functions to support Specialty Beauty Brands (NeoStrata, Exuviance, CoverBlend, RoC).  In addition to providing technical support to our international distributors, this person must collect the requisite regulatory documentation required for international pre-market registrations working cross functionally with multiple internal departments. The position also requires utilizing the product testing database to create claim support documentation for each product, which is a requirement of the FFC/APR dossier. Preparing documentation and serve as process lead to support product release for human use testing is also a requirement. The person will utilize strong critical thinking skills to identify and create needed documents and files and organize them in a logical standardized manner. They must communicate potential issues and questions to Clinical/R&D Scientists as well as Regulatory Associates. The right candidate must be customer-focused, detail-oriented, organized, approachable and energetic with the ability to multitask.  Excellent communication/organizational skills, knowledge of cosmetic/OTC regulatory/clinical documentation requirements and meticulous attention to detail are must have prerequisites.   
  • Collect, review and submit documentation to support international pre-market registrations for distributors based on the local Ministry of Health/Cosmetic Authority requirements
  • Access various registration documents including, but not limited to: formula certificates, clinical studies, certificates of analysis, stability, labeling, raw material/finished good specifications
  • Handle customer/distributor communications during the regulatory filings process
  • Respond to technical/clinical questions from distributors, including claim support
  • Work cross functionally with other regulatory and clinical partners as well as labeling and operations to ensure registration filings are completed and submitted on time
  • Utilize product testing database to create claims support files with all applicable clinical and claim support documents
  • Provide clinical/claim summary documentation for legacy products for the Fitness for Commercialization (FFC)/ Approval for Product Release (APR) files.
  • Prepare documentation and serve as process lead to support product release for human use testing
 

Qualifications
  • A Bachelor’s degree is required, preferably in chemistry, biological sciences or related scientific discipline with a minimum of 3 years of relevant experience or a Master’s degree with 0-2 years relevant experience.    
  • Experience in regulatory or clinical cosmetic product related documentation and/or international cosmetic pre-market registration process is preferred.
  • Knowledge of Good Manufacturing Practices or Good Clinical Practices is preferred
  • Excellent organizational skills and attention to detail is required
  • Experience working cross functionally within a broader organization
  • Must possess technical and critical thinking skills and the ability to work independently is required
  • Must have strong written and oral communication skills; must be proficient with Word, Excel and PowerPoint
   

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 


Primary Location
United States-New Jersey-Princeton
Organization
NeoStrata Company, Inc (6231)
Job Function
Regulatory Affairs
Requisition ID
3430181001