Openings For Regulatory Affairs - Biotechnology Department - MSN Laboratories, R&D; Center, Pashamylaram,

Regulatory Affairs , : ( Regulatory Affairs - Biotech Division ) Should have minimum of 07 to 15 years of experience

Job Title: deputy Manager / Assistant Manager

Experience: 10 -15 years in Biotech RA field

Education: M.Sc Biotechnology

Department : Regulatory Affairs - Biotech

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.
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 explicit 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

📌 Openings For For Regulatory Affairs Biotechnology Dept @ R&d Center Hyderabad (India)
🏢 MSN Group
📍 India