Career Opportunity: Regulatory Affairs (FML Division) at MSN Laboratories
Job Summary
* Position: Executive, Senior Executive, Junior Manager, or Assistant Manager
* Experience Required: 2 to 10 years of professional experience in FML Regulatory Affairs
* Education Qualification: B. Pharm or M. Pharm
* Location: MSN Laboratories, R&D Center, Pashamylaram, Hyderabad
* Event Date: Walk-in interview on Friday, April 24, 2026
Role Overview
MSN Laboratories is conducting a walk-in recruitment drive for experienced professionals to join our Regulatory Affairs team within the FML division. We are looking for dedicated individuals ranging from the Executive level to Assistant Manager who possess strong technical expertise in regulatory documentation, dossier compilation, and cross-functional collaboration. This role is pivotal in ensuring that our pharmaceutical products meet the rigorous standards required by regulatory authorities across various global markets.
Key Responsibilities
The successful candidate will be responsible for the end-to-end management of regulatory submissions. Your primary duties will include:
Documentation and Submissions: Collecting necessary data from various internal departments to prepare comprehensive regulatory submissions, including amendments, updates, and revisions. You will be responsible for compiling dossiers in both eCTD and CTD formats to ensure compliance with the requirements of various target countries.
Regulatory Liaison: Acting as a key point of contact for regulatory authorities. This involves drafting precise, technically sound responses to regulatory deficiencies and review comments. You will facilitate meetings with cross-functional teams to resolve identified gaps or queries from authorities and customers.
Strategic Guidance: Providing expert guidance to cross-functional teams based on current regulatory trends and requirements. You will plan and allocate project responsibilities within the team to ensure high-quality output and adherence to established timelines.
Lifecycle Management: Assessing proposed changes for approved products and determining the appropriate submission category. You will review and clear critical technical documents, including specifications, protocols, stability data, and bio-waiver information.
Database Management: Ensuring that all internal databases are updated accurately and in accordance with current organizational requirements.
Cross-Functional Collaboration: You will represent the Regulatory Affairs department in meetings with R&D, Production, Plant Quality Assurance, Quality Control, and Marketing teams. Furthermore, you will support plant teams during regulatory audits and maintain effective communication with domestic and international regulatory authorities. You will also be responsible for reviewing and approving change controls to ensure that all documentation remains current and compliant.
Key Performance Indicators (KPIs)
To be successful in this role, you must demonstrate:
* Comprehensive knowledge of regulatory guidelines and specific requirements for each market.
* A strong track record of meeting strict submission deadlines.
* The ability to provide actionable solutions to address regulatory queries and complex dossier challenges.
Required Skills and Qualifications
We are seeking candidates who possess a strong foundation in the pharmaceutical regulatory landscape. You should be proficient in navigating RA guidelines and have a practical understanding of how to resolve regulatory deficiencies. The ideal candidate will have 2 to 10 years of specific experience in the FML Regulatory Affairs field and hold a degree in B. Pharm or M. Pharm.
Interview Details
If you are a motivated professional looking to advance your career with a leading pharmaceutical company, we invite you to attend our upcoming walk-in interview.
* Date of Interview: Friday, April 24, 2026
* Venue: MSN Laboratories, R&D Center, Pashamylaram, Hyderabad
Please ensure you carry an updated copy of your resume, your educational certificates, and your experience letters. We look forward to meeting candidates who are passionate about regulatory excellence and contributing to the success of our global product portfolio.