Regulatory Affairs Specialist

2 days ago


Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Title: Regulatory Affairs Specialist

At Daiichi Sankyo Group, we are dedicated to creating innovative pharmaceutical therapies to improve standards of care and address unmet medical needs globally. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.

Job Summary

This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products.

Responsibilities
  • Preparation of new and updated Core Data Sheets, EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, EU PL, CCDS, CCPL) for new products or products in the development phase.
  • Ensure Compliance with Core Data Sheets/Label Changes: Develops and communicates strategic labeling development strategic plan to other project team members and ensures implementation of CCDS/labeling agreements with licensing partners.
  • Conduct Label Review Committee Meetings: Prepares documents for review by labeling teams and leads review processes to ensure appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.
  • Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings and manages compliance with internal and external guidelines.
Qualifications
  • Bachelor's Degree preferably in a scientific discipline required.
  • Advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred.
  • 10 or More Years pharmaceutical industry experience required.
  • 4 or More Years of direct regulatory affairs experience, including CCDS and US/EU labeling experience required.
Travel

Ability to travel up to 10% Occasional travel.



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