Key Points
- Position: Executive / Senior Executive / Junior Manager / Assistant Manager in Regulatory Affairs – FML Division
- Experience Required: 3 to 10 years in FML Regulatory Affairs
- Education: B.Pharm, M.Sc., or M.Pharm
- Job Location: MSN R&D Center, Pashamylaram, Hyderabad
- Walk-In Interview Date: 13th September 2024
Join MSN Group’s Walk-In Drive for Regulatory Affairs – FML Division!
Are you an expert in Regulatory Affairs with a passion for making an impact in the pharmaceutical industry? MSN Group, one of India’s fastest-growing pharmaceutical manufacturers, invites you to a walk-in interview for exciting positions in our FML Division. This is your chance to become part of a dynamic team at the forefront of API and finished dosage production.
About MSN Group
Established in 2003, MSN Group has rapidly expanded to become a leading name in the pharmaceutical industry. With eight API manufacturing plants (including one dedicated to Oncology), two finished dosage facilities (with another for Oncology in the pipeline), and a dedicated R&D Center, we’re on a growth trajectory of 30-40% annually. Our commitment to innovation and excellence drives our success, and we’re looking for talented individuals to join us on this exciting journey.
Position Overview
We’re looking for professionals with 3 to 10 years of experience in Regulatory Affairs specifically within the FML (Finished Market Licenses) Division. As an Executive, Senior Executive, Junior Manager, or Assistant Manager, you will play a crucial role in ensuring our products meet regulatory standards and gain market approval.
Key Responsibilities
- International Product Filing & Registrations: Handle the registration and life-cycle management of products in regulated and emerging markets. Ensure compliance with global and regional regulatory requirements.
- Regulatory Norms Expertise: Maintain a deep understanding of regulatory norms for various markets. Prepare and submit dossiers, renewal applications, and variations based on CTD, ACTD, and other region-specific requirements.
- Query Resolution: Address and respond to queries from regulatory agencies and local partners effectively.
- Technical Document Review: Provide regulatory feedback on technical documents, including process validation, AMV, stability studies, labeling, batch records, and specifications.
- Compliance Assurance: Ensure all documentation is accurate and compliant with regulatory standards.
- Artwork Approvals: Make recommendations for and approve artwork as per regulatory provisions.
- Cross-Functional Team Collaboration: Represent regulatory affairs in cross-functional meetings. Work closely with R&D, Production, QA/QC, and Marketing teams to streamline regulatory processes.
- Audit Support: Assist plant teams during regulatory audits and liaise with domestic and export regulatory authorities.
- Change Control Assessment: Evaluate and approve change controls, ensuring that all files are updated accordingly.
Walk-In Interview Details
Date: 13th September 2024
Location: MSN R&D Center, Pashamylaram, Hyderabad
Venue: M/s MSN Laboratories Pvt. Ltd., R&D Center, Plot No. 12 Phase IV, Industrial Park, Telangana State, Industrial Infrastructure Corporation, Pashamylaram (Village), Patancheru (Mandal), Medak (District), Telangana State 502 307
Contact: 0845-2304789 or 0845-230/4899/4799
What to Bring
- Resume
- Photo Copy of Educational Certificates
- Latest Increment Letter
- Last Three Months Pay Slips
- Last Six Months Bank Statements
- Passport Size Photographs
- Aadhar Card Copy
How to Reach Us
For more information, please contact:
Contact Person: MVVB Narasimha Raju
E-Mail: narasimharaju.manthena@msnlabs.com
Don’t miss this opportunity to advance your career with MSN Group, where innovation meets growth. We look forward to seeing you at our walk-in drive!
