Manager - Regulatory Affairs

Job Description

Prepare, coordinate, manage regulatory submissions for  Domestic market for In licensing,  Medical device at Sugam portal in accordance with applicable regulations.

1. Prepare, coordinate, manage regulatory submissions for Domestic Market for SND, ND, IND, CT-04, BA/BE and Post Approval changes in line with regulations.

1. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
2. Develop regulatory strategies and implementation plans for the preparation and submission
3. Review all regulatory submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards products.

6. Provide accurate comments during document review.
7. Able to handle multiple projects with good prioritization skills.
8. Well versed with Sugam portal Application system.

Work Experience

10 to 12 years of experience with handling Indian market - DCGI applications

Education

Competencies