Regulatory Affairs Specialist

Kolkata, India | Regulatory Affairs | 4-6 years

We are seeking an experienced Regulatory Affairs Specialist to join our team, responsible for managing regulatory submissions and ensuring compliance with global health authority requirements for our clinical programs.

Key Responsibilities:

• Prepare and review regulatory submissions (e.g., CTAs, INDs, amendments).
• Ensure all regulatory documents comply with applicable regulations and guidelines.
• Liaise with health authorities and ethics committees.
• Provide regulatory guidance to internal teams and clients.
• Maintain regulatory intelligence and stay updated on evolving regulations.
• Support regulatory inspections and audits.

Qualifications:

• Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
• 4-6 years of regulatory affairs experience in clinical research (pharmaceuticals or medical devices).
• In-depth knowledge of ICH-GCP, FDA, EMA, and CDSCO regulations.
• Strong attention to detail and excellent written communication skills.
• Ability to manage multiple projects and deadlines.

What We Offer:

• Competitive salary and performance incentives.
• Opportunity to work on diverse global projects.
• Professional development in regulatory science.
• Supportive and expert-driven team environment.
• Work-life balance initiatives.