Regulatory Affairs Specialist
Patna, Bihar, India · Full Time
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- Experience
- 3–8 yrs
- Salary
- —
- Openings
- 1
- Posted
- 3 weeks ago
- Work mode
- In office
- Education
- Ph.D.
- Eligibility
- Candidates with a Ph.D. in the listed life sciences, pharmacy, pharmaceutical sciences, molecular biology, biochemistry, microbiology, or biomedical sciences backgrounds, along with relevant regulatory affairs experience, may apply. RAC certification is preferred.
- Resume
- Required to apply
Where you'll work
Job description
Role Overview
The Regulatory Affairs Specialist will ensure that products remain aligned with all relevant national and international compliance requirements from development through market launch and beyond. The position involves supporting regulatory filings, keeping documentation current with changing rules, and acting as a bridge between regulatory agencies and internal teams.
Job Details
Department: Regulatory
Location: Bodh Gaya, Bihar, and Varanasi, Uttar Pradesh
Employment Type: Full-time, onsite
Experience: 3 to 8 years
Core Responsibilities
- Draft, evaluate, and file regulatory submissions for product registrations, renewals, amendments, and variations.
- Build and keep updated regulatory records and supporting documents in line with applicable standards and guidance.
- Track compliance obligations issued by authorities such as FDA, EMA, CDSCO, MHRA, TGA, PMDA, and other global regulators.
- Work with Research & Development, Quality Assurance, Manufacturing, Clinical, and Commercial functions to collect the documents needed for submissions.
- Manage regulatory files and make sure licenses, registrations, and certifications are renewed on time.
- Offer regulatory input during product development and throughout the product lifecycle.
Required Expertise
- Good command of international regulatory systems and submission workflows.
- Working knowledge of FDA, EMA, CDSCO, ICH, WHO, ISO, GMP, GLP, and GCP requirements.
- Hands-on experience with CTD and eCTD dossier preparation.
- Exposure to regulatory expectations for pharmaceuticals, biologics, diagnostics, or medical devices.
- Strong ability in scientific writing, documentation control, and technical review.
- Sound analytical thinking, organization, and problem-solving skills.
- Capability to handle several assignments at once and deliver within tight deadlines.
Qualification
A Ph.D. in Life Sciences, Pharmacy, Pharmaceutical Sciences, Molecular Biology, Biochemistry, Microbiology, or Biomedical Sciences is required. Regulatory Affairs certification (RAC) will be considered an advantage.
Additional Information
This role is based onsite. The source did not specify salary, perks, openings, application deadline, or joining date.