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

Regulatory Affairs , Job Description: ( Regulatory Affairs - Formulation R&D; Center ) Should have minimum of 02 to 06 years of experience

Job Title: Executive / Senior Executive

Experience: 02 -06 years in Formulation RA field

Education: M-Pharma

Department : Regulatory Affairs - Formulation

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 transparent 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 Regulatory Affairs -Formulation Dept @ R&D Center (Hyderabad)
🏢 MSN Group
📍 Hyderabad