MSN Laboratories, certified as a “Great Place to Work,” is seeking talented professionals for our API Regulatory Affairs Department. Join us at our state-of-the-art R&D center in Hyderabad and contribute to creating better medicines.
Position Details
Role: API Regulatory Affairs – Executive
Experience Required: 1-3 Years in the API Industry
Qualification: M.Sc.
Interview Date & Time: 13-December-2024, Friday, 09:00 AM
Location:
MSN Laboratories Pvt Ltd,
R&D Center, Pashamylaram,
Hyderabad, Telangana, 502307
Eligibility
- Candidates from R&D, AR&D, QA, and QC departments are welcome to apply.
- Must have less than 3 years of API industry experience.
- Note: Professionals with more than 3 years of experience are not eligible.
Job Description
Primary Responsibilities
- Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations. Ensure compliance with guidelines and regulations.
- Documentation Management: Maintain and update regulatory documentation, including DMFs (Drug Master Files), and review submissions for regulatory approvals and renewals.
- Compliance Assurance: Stay updated with regulatory guidelines, assess API products, and provide compliance recommendations.
- Communication: Interact with regulatory authorities, address inquiries, and manage inspections and audits as required.
Key Skills Required
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- Strong understanding of API regulatory processes.
- Expertise in handling equipment and compliance tools.
How to Apply
Contact:
Baratam Dinesh
📧 dinesh.baratam@msnlabs.com
📞 +91 9154811048
