Sr. Officer/Executive Jobs at Zenvision Pharma – Mumbai

Zenvision Pharma is hiring for Sr. Officer / Executive positions in its Regulatory Affairs department at Mahape MIDC, Navi Mumbai. The opportunity is intended for candidates with 2–4 years of experience and a qualification of B.Pharm, M.Pharm or M.Sc.

The role involves preparing and submitting regulatory applications, maintaining regulatory records, coordinating with regulatory authorities and supporting applications related to new drugs, subsequent new drugs, fixed dose combinations and clinical trials.

About Zenvision Pharma

Zenvision Pharma is a pharmaceutical company with a 20,000-square-foot R&D and manufacturing facility. The facility includes dedicated departments and resources intended to support the requirements of business partners and regulatory agencies in line with global formulation development standards.

The company states that its team includes professionals working across areas such as intellectual property, formulation and analytical sciences, regulatory affairs, quality assurance, sourcing and project management. These teams work together on formulation development projects.

Zenvision Pharma provides product development services for both generic and specialty pharmaceuticals. Its stated R&D activities range from product development and exhibit batches to the review and compilation of ANDAs and dossiers, supporting submissions for clients.

Zenvision Pharma Regulatory Affairs Vacancy

The available position is within the Regulatory Affairs department and involves regulatory application preparation, submission, follow-up and documentation activities.

• Position: Sr. Officer / Executive
• Department: Regulatory Affairs
• Location: Mahape MIDC, Navi Mumbai
• Experience: 2–4 Years
• Qualification: B.Pharm / M.Pharm / M.Sc.
• Gender: Male & Female candidates will be considered

Related Job: RA Executive Jobs at La Chandra Pharma Lab

Key Responsibilities

The selected professional will be involved in regulatory application preparation, submission, follow-up and maintenance of regulatory records.

1. Prepare and submit applications such as Test License, Additional Product, Loan License, Storage License and Certificates through the XLN India online system.
2. Prepare and submit applications including Form CT-11, Form CT-14, Procurement NOC, Dual Use NOC and Import License through the Sugam Portal.
3. Follow up with FDA, CDSCO and NCB departments regarding submitted applications.
4. Maintain and update records of applications submitted to Local FDA, CDSCO and NCB.
5. Prepare and submit DCGI applications for New Drugs, Subsequent New Drugs, Fixed Dose Combinations, Form CT-21, Clinical Trial Applications and Form CT-04
6. Coordinate with applicants regarding compliance-related queries raised by FDA and CDSCO authorities.
7. Plan and arrange Competent Technical Person interviews for candidates associated with various facilities.
8. Arrange Plan Layout Approval meetings by discussing requirements with FDA and CDSCO authorities.
9. Prepare, review and submit hard copies of various regulatory applications.
10. Visit government websites to stay updated on new circulars and guidelines relevant to regulatory activities.
11. The vacancy also mentions that the selected candidate may be assigned other responsibilities by the superior.

How to Apply

Interested candidates can share their updated CV for the Sr. Officer / Executive – Regulatory Affairs opportunity with Zenvision Pharma.

Email: hr@zenvisionpharma.com

Candidates should ensure that their CV contains updated educational and professional information relevant to the Regulatory Affairs position. No application deadline is mentioned in the supplied vacancy information. Candidates should confirm the current availability of the position and any additional recruitment requirements with the employer before applying.

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