22 July, 2022
Sun Pharma Hiring Manager – Regulatory Specialist, Clinical Trials
The position is to support global regulatory submissions for clinical trials as it pertains to all of SPARC’s development programs and life cycle management of Sun programs. The individual will be involved in creating, reviewing, approving, and/or submitting regulatory submission packages to global RAs in order to obtain approval to conduct clinical trials in those countries. In addition to RA submissions, this role will support study teams and site staff in submissions to local ECs/IRBs. As part of these responsibilities, the incumbent will review and approve essential documents for assigned studies.
What are the key responsibility of the role?
- Follow up with all stake holder departments to obtain technical documents required for Regulatory submissions.
- Preparation of documents for regulatory submissions
- Critically review documentation for submissions for consistency and quality as per relevant regulations.
- Essential document review and/or approval
- Coordinate with stakeholders to ensure timely and accurate submissions.
- Maintain annual approvals.
6 to 9 years in related field
Skills / Competencies
- Thorough understanding of ICH requirements and regulations.
- Regulatory submission experience globally (clinical trials).
- Regulatory agency direct interaction experience preferred. Expected to handle projects as independent contributor.