Pharmaceutical Regulatory Specialist

19 hours ago


Pune, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000
Job Title: Pharmaceutical Regulatory Specialist

The role of a Pharmaceutical Regulatory Specialist is to oversee the management of pharmaceutical and biological documentation, as well as registration applications for chemical active substances and biological medicinal products.

Key Responsibilities:
  • Ensure compliance with regulatory schedules as per the Drugs and Cosmetics Act, India GMP, and USFDA CGMP guidelines
  • Maintain Cell Therapy guidelines, USFDA guidelines, and EMA regulations
  • Develop and implement process validation and manufacturing process development strategies
  • Validate analytical procedures and stability data
Requirements:
  • Extensive knowledge of pharmacology, pharmacokinetics, toxicokinetic, toxicology, genotoxicity, carcinogenicity, local tolerance, safety pharmacology studies for human pharmaceuticals, single dose toxicity, and repeated dose toxicity
  • Validated analytical methods and analytical methodology expertise
  • Proven experience in process validation and manufacturing process development
Additional Skills:
  • Clinical trial preparation and clinical study reports development
  • Efficacy and safety studies expertise
  • Post-marketing experience and statutory fulfillment requirements
  • Effective communication and presentation skills for meetings with regulatory agencies, CROs, national & international authorities
About the Role:

This role requires a highly skilled individual to manage complex regulatory documents and ensure compliance with industry standards. The ideal candidate will have excellent analytical and problem-solving skills, as well as the ability to communicate effectively with stakeholders.



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