MSN Laboratories Pvt. Ltd Walk-in 27th June for Multiple positions

MSN Laboratories Pvt. Ltd Walk-in Interview.MSN Laboratories Pvt. Ltd Notification full details below. Interested and eligible candidates can attend Interview on scheduled time and venue.

Vacancy details:

• Position: FML Regulatory Affairs Dept (FML – RA) @ R&D Center
• Qualification : B Pharm \ MSc \ M Pharm
• Experience: 2-7 Years
• Jyothi Korra ( 04030438787 )

Important Details :

• Selection Process: The selection will be on the basis of Interview.
• Mode of Interview: Face to face
• Interview Rounds of Interview: HR

Walk-In Drive For Regulatory Affairs – FML Department in FML Division – MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025.

Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs – FML Division ) Should have minimum of 02 to 07 years of experience in FML Regulatory Affairs

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

Walk-In Drive For Regulatory Affairs – FML Department in FML Division – MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025.

Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs – FML Division ) Should have minimum of 08 to 13 years of experience in FML Regulatory Affairs

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

Interview Date : 27-05-2025

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

Interview Venue: MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 27-06-2025.

Contact – M B V V N Raju ( 9100376029 )