Clinical Project Assistant
Sanofi
Advertisement
Job Description
Location: Baroda, Tandalja – R&D
Job Requisition ID / Job Grade: G12A
Job Category: R&D1 Regulatory Affairs
Job Type: Full-Time
About the Role
Sun Pharmaceutical Industries Ltd is seeking an Executive – Regulatory Affairs to join its dynamic R&D team. This role plays a key part in ensuring timely regulatory approvals and maintaining compliance for products across MENA markets. The ideal candidate will manage regulatory submissions, lifecycle management, and responses to queries, enabling seamless market access and regulatory compliance.
At Sun Pharma, we are committed to helping you “Create your own sunshine” by fostering an environment where you grow continuously, take charge of your career, and thrive within a collaborative community.
Role & Responsibilities
- New Submissions / Renewals:
- Review and prepare CMC (Chemistry, Manufacturing, and Controls) dossiers for new submissions.
- Assess development reports, scale-up reports, specifications, stability protocols, artworks, etc., before initiating exhibit batches.
- Review and prepare CMC (Chemistry, Manufacturing, and Controls) dossiers for new submissions.
- Approval:
- Review and prepare responses to deficiencies to enable timely regulatory approvals.
- Review and prepare responses to deficiencies to enable timely regulatory approvals.
- Lifecycle Management for Drug Formulations:
- Prepare and review variations per country-specific requirements to support approvals for API vendor changes, test parameter modifications, DF site changes, and product harmonization.
- Prepare and review variations per country-specific requirements to support approvals for API vendor changes, test parameter modifications, DF site changes, and product harmonization.
- Regulatory Compliance:
- Prepare, review, and circulate approval packages with product history sheets to stakeholders and update them based on queries or variations.
- Ensure repositioning of comprehensive product information into the central repository.
- Review regulatory filing impact of variations, change controls, and related updates.
- Prepare, review, and circulate approval packages with product history sheets to stakeholders and update them based on queries or variations.
Educational Qualification
- Graduate: M.Sc / M.Pharm
Experience & Skills
- 1–4 years of relevant experience in regulatory affairs.
- Strong knowledge of regulatory submissions, lifecycle management, and MENA regulatory requirements.
- Excellent attention to detail and ability to manage multiple submissions and approvals simultaneously.
- Effective communication, collaboration, and problem-solving skills.
Location
Baroda, Tandalja – R&D
Advertisement
Recent Jobs
Clinical Research Associate 1
AstraZeneca
CTIS Administrator
Parexel
Clinical Research Associate (Level I, Level II & Sr. CRA)
Thermo Fisher Scientific
Associate Clinical Study Manager
Novartis
eClinical Coordinator
Medpace
Pharmacovigilance Services Associate
accenture
Associate – Regulatory Affairs
CLINCHOICE