Regulatory Affairs Executive Pharmaceutical Industry

1 day ago

Mumbai, Maharashtra, India Mahesh Bhupatrai Mehta Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Job Title: Regulatory Affairs Executive Pharmaceutical Industry

Company: Classic Enterprise

Location: Synergy Court, Malad West, Mumbai – 400064

Industry: Pharmaceuticals

Employment Type: Full-time

Experience Required:6-8 years

About Us:

Classic Enterprise is a Mumbai-based pharmaceutical company located in the heart of Malad West. With a growing footprint in international markets, we are committed to delivering high-quality healthcare solutions. Our regulatory affairs team plays a critical role in ensuring compliance with national and international regulatory standards.

Key Responsibilities:

  • Prepare, compile, and review regulatory submissions for international markets (e.g., FDA, CDSCO, WHO, EU & ROW)
  • Maintain product registrations and licenses, ensuring timely renewals and updates.
  • Monitor changes in regulatory guidelines and communicate updates to relevant departments.
  • Liaise with regulatory authorities and respond to their queries or deficiency letters.
  • Assist in compiling dossiers for product approvals (CTD, ACTD formats, etc.).
  • Coordinate with R&D, QA/QC, and manufacturing departments for required documentation.
  • Maintain accurate and up-to-date regulatory documentation and databases.
  • Support audits and inspections by regulatory bodies or third-party clients.

Qualifications:

  • B.Pharm / M.Pharm / M.Sc in Regulatory Affairs or related field.
  • 6–8 years of experience in a regulatory affairs role within the pharmaceutical industry (preferred).
  • Familiarity with global regulatory requirements (e.g., ICH, EU, USFDA, ROW).
  • Strong attention to detail, analytical thinking, and communication skills.
  • Proficient in MS Office and regulatory software tools.

Preferred Skills:

  • Experience with eCTD submissions
  • Knowledge of pharmacovigilance and clinical trial regulations
  • Understanding of GMP, GLP, and ISO standards

What We Offer:

  • Competitive salary and performance-based incentives
  • A supportive and collaborative work environment
  • Opportunities for professional growth and training
  • Exposure to international regulatory processes

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