Walk in Drive API Regulatory Affairs Dept (RA).

Job Description

Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center Work/Interview Location :- MSN R&D Center, Pashamylaram, Isnapur, Telangana Interview Date:- 05-07-2025 @Saturday Interview Time :- 9AM TO 2PM Venue Details : MSN Laboratories Pvt. Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy Contact :- 9154811048 Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 1-7 years of regulatory affairs experience in the pharmaceutical industry. Key Responsibilities: Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. Documentation Management: Maintain, review, and update regulatory documentation, including drug master files (DMFs) and technical files, to support product registrations and renewals. Compliance Assurance: Stay up-to-date with regulatory changes, assess the impact on products, and provide recommendations for maintaining compliance. Communication: Interact with regulatory authorities, addressing inquiries, requests, and managing inspections and audits as required. Cross-functional Collaboration: Work closely with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance and support for API-related activities. Quality Standards: Ensure that API products meet quality and safety standards in alignment with Good Manufacturing Practices (GMP) and other relevant quality regulations. Regulatory Strategy: Contribute to the development of regulatory strategies for product development and lifecycle management. Position : Executive Qualification : M.sc Work Location : MSN R&D Center, Pashamylaram. Department : API Regulatory Affairs Dept - ( API RA ) Experience : 1 to 7 Years Job Location : MSN Laboratories Pvt.Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy Interested Candidates can share there CVs to dinesh.baratam@msnlabs.com