Openings For For Regulatory Affairs -Biotechnology Dept @ R&D Center

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

Regulatory Affairs , Job Description: ( 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 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