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Regulatory Affairs Executive | Freshers and Experienced
About Sain Medicaments Pvt. Ltd.
Sain Medicaments Pvt. Ltd. is a leading pharmaceutical formulation company serving human healthcare since the 1970s. The company has an ISO 22000:2005, WHO GMP, and GLP certified manufacturing unit situated in Hyderabad.
Position Name: Regulatory Affairs Executive
Organization: Sain Medicaments Pvt. Ltd.
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc
Experience: 0 Years / Freshers – 2 Years
Salary: ₹25,000 – ₹35,000 per month
Location: Uppal, Telangana
Responsibilities
- Preparation of Regulatory Dossiers:
- Coordinate and collect data/documents from various departments.
- Review for compliance before dossier preparation.
- Vendor and Manufacturer Coordination:
- Contact API vendors and manufacturers for DMFs/APIMFs/Tech packs.
- Review documents and ensure compliance with CTD requirements.
- Artwork Development Coordination:
- Coordinate with graphic designers for labels and packaging material artwork.
- Sample Planning for Registration:
- Plan for registration samples in coordination with concerned departments.
- Ensure readiness as per the submission plan.
- Handling Queries:
- Handle queries from clients and drug authorities.
- Provide required information/documents within stipulated timelines.
Knowledge and Skills Required
| Skill | Description |
|---|---|
| Regulations and Compliance | Explain regulations, policies, or procedures and ensure adequate compliance. |
| Technical Review | Provide correct and accurate technical review of data or reports. |
| Documentation Management | Oversee planning, coordination, and management of regulatory documentation activities. |
| Regulatory Guidelines Interpretation | Examine, identify, and interpret relevant regulatory guidelines. |
| Impact Analysis | Analyze and evaluate laws and regulations to determine the impact on company activities. |
| Regulatory Documentation | Compile and oversee maintenance of regulatory documentation databases or systems. |
| Submission Preparation | Coordinate efforts related to the preparation of regulatory documents or submissions. |
| Communication with Regulatory Agencies | Develop and maintain healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review. |
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