Senior Regulatory Affairs Executive

Titan Laboratories; Navi Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Titan Laboratories Pvt Ltd. seeks an experienced Regulatory Affairs professional to prepare, review and submit dossiers (DMF, CEP, CTD/ECTD) for diverse markets.

You will handle deficiency responses and coordinate with authorities and customers, while maintaining regulatory documents across QA, QC, production and R&D teams. The role requires strong communication, documentation, and timeline management to ensure on-time submissions and regulatory compliance.

Qualifications

• Strong communication and coordination abilities.
• Excellent documentation and record management.
• Sound problem-solving and analytical skills.
• Effective follow-up and timeline management.

Responsibilities

• Prepare and submit regulatory dossiers (DMF, CEP, CTD/ECTD) for multiple markets.
• Handle deficiency responses and regulatory queries with authorities and customers.
• Maintain and update regulatory documents including specs, methods, process descriptions and stability data.
• Coordinate with QA, QC, production, R&D and supply chain to gather required documents and data.
• Manage submission timelines, approvals, renewals and annual reports.
• Support regulatory inspections and follow-up actions.

Skills

Communication

Coordination

Documentation

Record management

Problem solving

Analytical skills

Follow-up and timelines

Education

M. Pharm

Job description

Role & responsibilities

• Prepare review and submit rewarding dossier (DMF, CEP, CTD/ECTD, Korean DF, Brazil DMF (Anvisa Technical packages) for various markets.
• Handled deficiency responses, query management and correspondence with regulatory authorities & Customers.
• Maintain and update regulatory documents, including specification, analytical methods, process description and stability data.
• Co-ordinate with QA, QC, production R & D and supply chain collection of required documents and data.
• Truck submission timelines, approval, renewals and annual reports.
• Support preparation for regulatory inspection and follow up actions.

Preferred candidate profile

• Strong communication and coordination skills
• Good documentation and record management ability
• Sound problem-solving and analytical skills
• Effective follow-up and timeline management

Qualifications (must-have and preferred) & Experience:

• M. Pharm
• 8+ Years in Regulatory Affairs

Titan Laboratories Pvt Ltd.