Mendine Pharmaceuticals Pvt. Ltd. is hiring an experienced Regulatory Affairs Specialist for its team in Kolkata, West Bengal.
Candidates with an M.Pharm qualification and at least 5 years of experience in pharmaceutical regulatory affairs are eligible to apply.
The role requires hands-on experience in domestic regulatory documentation, licence renewals, amendments, and the ONDLS portal.
Professionals with experience coordinating with CDSCO and regulatory authorities, along with export and COPP documentation exposure, will be preferred.
Mendine Pharmaceuticals Regulatory Affairs Specialist Recruitment
Mendine Pharmaceuticals Pvt. Ltd. is inviting applications for the position of Regulatory Affairs Specialist. The opportunity is suitable for experienced professionals with knowledge of Indian pharmaceutical regulations, domestic licensing procedures, and regulatory documentation.
Candidates with relevant experience in regulatory submissions, licence renewals, amendments, and coordination with regulatory authorities can apply for this position in Kolkata.
Company Overview
Mendine Pharmaceuticals Pvt. Ltd. is a pharmaceutical company seeking an experienced professional to support its Regulatory Affairs activities. The current opening focuses on domestic regulatory requirements and related documentation.
Job Role & Responsibilities
Regulatory Affairs Specialist
The selected candidate will be responsible for supporting regulatory documentation and compliance activities related to pharmaceutical products in the Indian market.
Key responsibilities and areas of expertise include:
- Handling domestic regulatory documentation for the Indian pharmaceutical market.
- Managing licence renewals and amendments.
- Working with the ONDLS portal for applicable regulatory activities.
- Coordinating with the Central Drugs Standard Control Organisation (CDSCO) and other regulatory authorities.
- Supporting export-related regulatory documentation.
- Handling COPP documentation.
- Maintaining regulatory records and supporting compliance with applicable requirements.
Eligibility & Qualifications
Educational Qualification
- M.Pharm
- Specialisation or certification in Regulatory Affairs is preferred.
Experience Required
- Minimum 5 years of experience in pharmaceutical Regulatory Affairs.
- Hands-on experience with domestic regulatory documentation.
- Experience in licence renewals and amendments.
- Familiarity with the ONDLS portal.
- Experience coordinating with CDSCO and other regulatory authorities.
- Exposure to export and COPP documentation is preferred.
Location & Salary
- Company: Mendine Pharmaceuticals Pvt. Ltd.
- Job Location: Kolkata, West Bengal.
- Salary: Not specified in the recruitment announcement.
How to Apply
Interested and eligible candidates can send their updated CV to the recruitment email address below.
- Email: atrayee.mandal@mendine.com
- Website: www.mendine.com
Candidates should highlight their Regulatory Affairs experience, domestic regulatory documentation expertise, licence renewal experience, and coordination with CDSCO in their resumes.
Frequently Asked Questions
1. Which company is hiring for the Regulatory Affairs Specialist position?
Mendine Pharmaceuticals Pvt. Ltd. is recruiting for this position.
2. What qualification is required?
Candidates should have an M.Pharm qualification. Regulatory Affairs specialisation or certification is preferred.
3. How much experience is required?
Applicants must have at least 5 years of experience in pharmaceutical Regulatory Affairs.
4. What skills are preferred for this role?
Experience in domestic regulatory documentation, licence renewals, amendments, ONDLS portal activities, and coordination with CDSCO is required. Export and COPP documentation experience is preferred.
5. Where is the job located?
The position is based in Kolkata, West Bengal.
6. How can candidates apply?
Candidates can email their updated CV to atrayee.mandal@mendine.com.
Job Summary
| Category | Details |
|---|---|
| Company | Mendine Pharmaceuticals Pvt. Ltd. |
| Vacancies | Regulatory Affairs Specialist |
| Required Education | M.Pharm; Regulatory Affairs specialisation/certification preferred |
| Experience | Minimum 5 years in pharmaceutical Regulatory Affairs |