Job Description
Prepare, coordinate, manage regulatory submissions for Domestic market for In licensing, Medical device at Sugam portal in accordance with applicable regulations.
- Prepare, coordinate, manage regulatory submissions for Domestic Market for SND, ND, IND, CT-04, BA/BE and Post Approval changes in line with regulations.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Develop regulatory strategies and implementation plans for the preparation and submission
- Review all regulatory submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards products.
- Provide accurate comments during document review.
- Able to handle multiple projects with good prioritization skills.
- Well versed with Sugam portal Application system.
Work Experience
10 to 12 years of experience with handling Indian market - DCGI applications
Education
Graduation in Pharmacy or Pharmacy
Masters in Pharmacy or Pharmacy
Competencies
Innovation & Creativity
Result Orientation
Collaboration
Customer Centricity
Developing Talent
Stakeholder Management
Strategic Agility
Process Excellence
