Regulatory Affairs Officer

5 days ago

Hyderabad, Telangana, India Weekday AI Full time ₹ 9,00,000 - ₹ 12,00,000 per year

This role is for one of the Weekday's clients

Salary range: Rs Rs ie INR LPA)

Min Experience: 3 years

Location: Hyderabad

JobType: full-time

We are seeking a detail-oriented Regulatory Affairs Officer with 2–8 years of experience to join our team in Hyderabad, Nacharam. The ideal candidate will have expertise in Drug Master Files (DMF), ICH guidelines, and licensing processes, particularly within the botanical and herbal healthcare domain. This role is responsible for ensuring regulatory compliance, driving product registrations, and maintaining approvals across domestic and international markets.

Requirements

Key Responsibilities:

  • Prepare, compile, and submit Drug Master Files (DMF) and other regulatory dossiers for botanical and herbal healthcare products.
  • Ensure compliance with ICH guidelines and Indian regulatory requirements, including CDSCO norms.
  • Manage licensing, registrations, renewals, and variations with regulatory bodies.
  • Serve as the primary point of contact between regulatory authorities and internal departments to resolve queries effectively.
  • Monitor regulatory updates and implement necessary changes to maintain compliance.
  • Provide regulatory guidance to R&D and quality assurance teams during product development and manufacturing.
  • Maintain accurate regulatory documentation and track submission timelines.
  • Support regulatory inspections and audits.
  • Develop and execute regulatory strategies tailored to botanical and herbal healthcare products for different markets.

Qualifications:

  • Bachelor's degree in Pharmacy, Life Sciences, or a related field (advanced degrees preferred).
  • 2–8 years of experience in regulatory affairs, ideally within botanical or herbal healthcare.
  • Demonstrated experience in DMF preparation and submission.
  • Strong knowledge of ICH guidelines (Q7, Q9, Q10, Q11) and Indian regulatory framework (CDSCO).
  • Proven track record in managing licensing and registration processes for healthcare products.
  • Excellent communication and documentation skills.
  • Strong organizational and collaborative working abilities.

Preferred:

  • Experience with regulatory submissions to global agencies such as US FDA, EMA, etc.
  • Familiarity with GMP requirements for botanical/herbal products.
  • Understanding of safety and efficacy documentation for herbal healthcare.

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