Regulatory Affairs Officer

This role is for one of the Weekday's clients

Salary range: Rs 250000 - Rs 750000 (ie INR 2.5-7.5 LPA)

Regulatory Affairs Officer

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