Regulatory Compliance Specialist

12 hours ago

Pune, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 18,00,000
Job Title: Regulatory Compliance Specialist

Job Description

Our organization is seeking a skilled regulatory compliance specialist to oversee the management of pharmaceutical and biological documentation, as well as registration applications for chemical active substances and biological medicinal products. The successful candidate will be responsible for maintaining cell therapy guidelines, USFDA guidelines, and EMA.

The ideal candidate will have extensive knowledge of pharmacology, pharmacokinetics, toxicokinetic, toxicology, genotoxicity, carcinogenicity, local tolerance, safety pharmacology studies, single dose toxicity, repeated dose toxicity, clinical trials, and post-marketing experience.

Required Skills and Qualifications
  • Excellent understanding of regulatory affairs principles and practices.
  • Knowledgeable in CPMP-ICH or CPMP guidelines.
  • Experience in process validation and manufacturing process development.
  • Skilled in validation of analytical procedures and stability data.
  • Adventitious safety evaluation and process validation scheme for drug product.
  • Extensive knowledge of regulatory requirements and compliance.
Benefits

We offer a competitive salary package, opportunities for career growth, and a dynamic work environment. If you are a motivated and detail-oriented individual with a passion for regulatory compliance, we encourage you to apply for this exciting opportunity.

Others

The successful candidate will be required to present and conduct meetings with regulatory agencies, CROs, national & international authorities, and report weekly, monthly, quarterly, yearly meetings, updates, improvements.

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