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)
🏢 MSN Group
📍 Hyderabad