Posted:2 weeks ago|
Platform:
Work from Office
Full Time
Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center
Work Location :- MSN Laboratories Pvt. Ltd.
MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy
Interview Date:- 25-10-2025 @Saturday & 26-10-2025 @Sunday
Interview Time :- 9AM TO 5PM
Venue Details :
Ward No- 58, 31-41/10/1, Duvvada, Revenue, Visakhapatnam, Andhra Pradesh 530046
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.
MSN Laboratories Pvt.Ltd.,
MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy
MSN Group
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