Senior Specialist Regulatory Affairs
On-site · Delhi, Delhi, India
Job Summary
Senior Regulatory Affairs professional based in Delhi with 8-12 years of regulatory experience, responsible for liaising with CDSCO/State regulators, reviewing/submitting applications for drugs, vaccines, biologics, BE studies, cosmetics, and medical devices; tracking licenses and renewals; preparing regulatory submissions for clinical trials and marketing authorisations; maintaining MIS; developing regulatory strategies; ensuring compliance across product development and post-approval activities; strong English communication and teamwork skills; willingness to travel for regulatory meetings and inspections.
Required Qualifications
- Completed university degree in pharmacy, biology or chemistry (or a comparable degree)
- Educational qualification: B.Pharma/ M.Pharma/ Life Science Graduate or PG
- Very good written and spoken English
- General IT affinity & good MS Office skills
- Ability to work in a team, analytical thinking, flexibility, strong communication skills
- Willingness to travel for regulatory meetings and inspections
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