Virchow Biotech Private Limited is hiring a Senior Executive – Regulatory Affairs for its regulatory team.
The role focuses on National Regulatory Affairs, CDSCO and State FDA / DCA submissions.
Candidates with pharmaceutical regulatory affairs experience and prior r-DNA regulatory experience can apply.
The position requires 3–6+ years of experience, with M.Pharm in Regulatory Affairs preferred.
Virchow Biotech – Regulatory Affairs Department
Senior Executive – Regulatory Affairs
Department: Regulatory Affairs
Area: National Regulatory, CDSCO & State FDA / DCA
Experience: 3–6+ Years in Pharmaceutical Regulatory Affairs
Salary: As per present package
Location: Hyderabad, Telangana
Scope of Work – Regulatory Affairs
Scope 01: Regulatory Submissions
- Registrations & renewals
- Variations & amendments
- Licences & permissions
- NOC applications
Scope 02: Regulatory Compliance
- CDSCO & State FDA filings
- Deficiency responses
- Label & artwork review
- Audit & inspection support
Eligibility & Qualifications
Educational Qualifications
B.Pharm | M.Pharm | M.Pharm in Regulatory Affairs
M.Pharm in Regulatory Affairs is preferred for the position.
Experience Requirements
- 3–6+ years of experience in pharmaceutical Regulatory Affairs.
- Previous r-DNA regulatory experience is mandatory.
- Experience with ODLS, NSWS, CDSCO Sugam, CDSCO MD and ONDLS is required.
- Knowledge of Drugs & Cosmetics Rules, GMP and ICH requirements.
Required Regulatory Knowledge
Candidates should have relevant knowledge and experience in:
- r-DNA regulatory submissions
- CDSCO regulatory requirements
- State FDA / DCA requirements
- Regulatory registrations and renewals
- Variations and amendments
- Licences and permissions
- NOC applications
- Deficiency responses
- Label and artwork review
- Audit and inspection support
- Drugs & Cosmetics Rules
- GMP
- ICH requirements
Must-Have Requirement
Previous r-DNA regulatory experience is mandatory for this position.
Documents Required
Candidates are requested to bring the following documents:
- Updated CV
- One passport-size photograph
- Last three payslips
- Bank statement
- Increment letter
- Original educational and experience certificates
- Government photo identity proof
How to Apply
Interested candidates can send their updated CV to:
Candidates should mention “Sr. Executive – Regulatory Affairs” in the subject line of the email.
Contact Details
Phone: +91 91001 25845
Email: hr@virchowbiotech.com
Walk-In / Interview Venue
Virchow Biotech Private Limited
Unit – I, Gagillapur,
Hyderabad – 500043, Telangana.
Only shortlisted candidates will be contacted.
Job Summary
| Company | Virchow Biotech Private Limited |
|---|---|
| Vacancies | Senior Executive – Regulatory Affairs |
| Required Education | B.Pharm / M.Pharm / M.Pharm in Regulatory Affairs |
| Experience | 3–6+ Years in Pharmaceutical Regulatory Affairs |