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Regulatory Affairs Manager

Bridgewater, New Jersey
Regulatory Affairs Manager - Pharma
Bridgewater, NJ or Remote

  • Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels.
  • Demonstrated knowledge and understanding of company Core Data Sheets (CDS) and the dynamics of Labeling Team purpose and objectives.
  • Consolidate labeling versions and comments from Labeling reviewers and Regulatory Authorities.
  • Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).
  • Prepare comparison tables for labeling team discussions.
  • Manage the document status and notify internal stakeholders of the availability of labeling documents.
  • Finalize documents post QC
  • Order SPL for USPIs, notify internal stakeholders of its availability (e.g., Regulatory, Drug Listing).
  • Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts.
  • Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
  • Proficient in speaking publicly to senior management when required
  • Must be able to construct a Company Response (MAH response) for health authority questions
  • Understanding of key regulatory and Labeling principles and SOPs

Sudhanshu Karmalkar
Technical Recruiter
ReqRoute, Inc
Phone: 415-691-4708
Email: sudhanshu@reqroute.com

Companies across U.S. have engaged ReqRoute, Inc to deliver skilled, dedicated IT professionals. Recruiting is our passion and we support Fortune 1000 companies with their hiring needs. We always seek to deliver competitive and sought-after career opportunities to our potential consultants and employees. We invite you to review the position requirements and apply today if your skills match our needs.  
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. (www.reqroute.com)

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