MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA.
The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following:
- More than 900+ national and international patents
- Product portfolio featuring over 450 + APIs
- 300+ Formulations, covering over 35 major therapies
- Won the trust of more than 40 Million patients across 80+ countries globally
Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
DATE AND TIME:
Date : 27-06-2025
Venue: MSN Laboratories, R&D Center, Pashamylaram, Hyderabad .
Contact – M B V V N Raju ( 9100376029 )
Department : Regulatory Affairs – FML Dept.
Experience : 08 to 13 Years
Position: Asst. Manager / Deputy Manager / Manager / Sr Manager
Work Location : MSN R&D Center, Pashamylaram, Hyderabad
JOB DETAILS:
- Position: FML Regulatory Affairs Dept (FML – RA) @ R&D Center
- Qualification : B Pharm \ MSc \ M Pharm
- Experience: 2-7 Years
- Jyothi Korra ( 04030438787 )
Job Title: Executive / Senior Executive / Junior Manager
Experience: 02 to 07 years in FML RA field Candidates Only.
Department : Regulatory Affairs – FML
Markets : China, Europe, Australia, US, ROW
Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills
Role & responsibilities
International Product filing Registrations and life-cycle management
Expertise in Regulatory Norms for regulated markets / emerging market.
dossiers, renewal & variation applications for various markets based on CTD, ACTD and/or other region-specific requirements.
Respond to queries raised by regulatory agencies and/or local partners of the above regions.
Review and give regulatory feedback on technical documents like process validation, AMV, Stability and composition, labeling, batch records, specification or test methods, etc. Ensure accuracy and compliance of documentation.
Artwork recommendations and approvals as per regulatory provisions.
Well-versed in ICH guidelines, maintain awareness of legislation and current developments in regulatory affairs
Cross-Functional Team Work
Represent regulatory affairs at cross functional meetings and coordinate with R&D, Production, Plant QA/QC and Marketing to efficiently and successfully complete regulatory activities
Support plant teams in regulatory audits, liaison with domestic & export regulatory authority.
Assess and approve change controls and update files accordingly .
Interested candidates share their CV to
narasimharaju.manthena@msnlabs.com
Job Title: Asst. Manager / Deputy Manager / Manager / Sr Manager
Experience: 08 to 13 years in FML RA field
Education: B Pharm \ MSc \ M Pharm
Department : Regulatory Affairs – FML
Roles & Responsibilities :
- Collect documents from various departments to prepare regulatory submissions.
- Prepare regulatory submissions to relevant authorities.
- Prepare amendments, updates, and revisions to submissions.
- Conduct meetings with cross-functional teams (CFT) to address deficiencies received from regulatory authorities and customers.
- Draft responses to regulatory deficiencies and review comments.
- Update the database as per requirements.
- Prepare the applicant and restricted parts for Abbreviated New Drug Applications (ANDAs).
- Compile dossiers in electronic Common Technical Document (eCTD) and Common Technical Document (CTD) formats for all relevant countries.
- Guide the CFT based on current requirements from regulatory authorities.
- Plan and allocate projects within the team.
- Assess proposed changes for approved products and finalize the submission category.
- Review and clear specifications, protocols, stability data, bio-waivers, etc.
Key Performance Indicators:
- Demonstrate in-depth knowledge of regulatory guidelines and requirements for each market.
- Ensure all submissions are cleared within the stipulated timeline.
- Provide actionable items to address regulatory queries and dossiers.
Required skills:
- Knowledge of RA Guidelines and Requirements
- Action Item for RA deficiency.
Cross-Functional Team Work
- Represent regulatory affairs at cross functional meetings and coordinate with R&D, Production, Plant QA/QC and Marketing to efficiently and successfully complete regulatory activities
- Support plant teams in regulatory audits, liaison with domestic & export regulatory authority.
- Assess and approve change controls and update files accordingly
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