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Are you a seasoned pharmaceutical professional looking for a leadership role in regulatory compliance? Zenotech Laboratories Limited, a subsidiary of Sun Pharma, is currently expanding its team and seeking qualified individuals for the position of Senior Executive or Manager in Regulatory Affairs and Liaisoning.
This is a strategic opportunity for candidates with deep expertise in formulation and a strong track record of navigating the complex landscape of regulatory portals and local authorities.
Role Overview and Requirements
Zenotech is looking for candidates who can bridge the gap between technical formulation and regulatory approval. The ideal applicant will have extensive experience in the Formulation unit, specifically dealing with Orals, Non-Orals, and Biologics.
To be eligible for this role, you should meet the following criteria:
- Qualification: B. Pharm or M. Pharm.
- Experience: 4 to 8 years of relevant experience in Regulatory Affairs or Liaisoning.
- Location: The role is focused on the Telangana region, particularly regarding state-specific regulatory portals.
Key Responsibilities
The Senior Executive or Manager will be responsible for the end-to-end lifecycle of regulatory applications. Key duties include:
- Portal Management: Mastering the Online ODLS portal for Telangana as well as the national ONDLS portal for filing and tracking applications.
- Documentation: Preparing various application forms and ensuring every submission adheres to strict checklists and compliance standards.
- Liaisoning: Acting as the primary point of contact for local regulatory authorities to discuss application status and facilitate approvals.
- Submission Tracking: Maintaining a “hands-on” approach to tracking application progress and resolving queries from regulatory bodies efficiently.
Why Join Zenotech Laboratories?
Working with Zenotech means being part of a larger ecosystem backed by Sun Pharma, one of the world’s leading pharmaceutical companies. This role offers a platform to manage high-stakes regulatory submissions for diverse products, including advanced Biologics, providing a challenging yet rewarding career path for regulatory specialists.
