Regulatory Affairs

from 4 to 9 year(s) of Experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

  1. To support Life cycle management requirements at plant level in coordination with CRA API / Quality assurance and manufacturing.
  2. To Support DMF filing and Deficiency responses and provide appropriately reviewed data generated at plant level.
  3. To review change controls and propose Category of submission at various markets. To review specifications & test methods of raw materials, packaging materials and API for routine revisions.
  4. To check regulatory adequacy of API batches manufactured at manufacturing site to support regulatory filings.
  5. To provide regulatory support to API manufacturing sites during Customer & Regulatory Audits.

Desired Candidate Profile

To update API manufacturing sites about approval of various regulatory submissions and to ensure implementation of proposed changes involved in corresponding submission.


Perks and Benefits

Best in the Industry


Role:Regulatory Affairs Manager

Salary: Not Disclosed by Recruiter

Industry:Pharma, Biotech, Clinical Research

Functional Area:Legal, Regulatory, Intellectual Property

Role Category:Drug Regulatory Affairs/Documentation

Employment Type:Full Time, Permanent

Education-

UG:Any Graduate in Any Specialization

PG:Any Postgraduate in Any Specialization

Doctorate:

Company Profile

ZCL CHEMICALS LTD

We are USFDA, EDQM ,KFDA ,COFEPRIS ,PMDA,WHO GMP, certified Company.


ZCL CHEMICAL LTD (formerly known as Zandu Chemicals Ltd.) was founded in 1991. ZCL is engaged in manufacturing of Active Pharma Ingredients for Pharmaceutical companies.


It is a 100% Export Oriented Unit (EOU) that combines the power of science and technology. The company is headquartered in Mumbai and has clients across the globe.


The R&D Center and cGMP- manufacturing facility is in the Industrial heart of Ankleshwar city in Gujarat. The Company delivers a broad range of advanced intermediates and active ingredients for pharmaceutical end use and services to customers around the world. Custom synthesis, Long term contractual manufacturing under secrecy, Exclusive manufacturing under CDA, Contract Research work from milligram to kilo scale.


ZCL is known for tailor-made the products to solve the challenges of customers.

Company Info
View Contact Details+

Contact Company:ZCL CHEMICALS LTD

Address:PLOT NO 3102/B,,ZCL CHEMICALS LTD,GIDC,ANKLESHWAR, , , BHARUCH, Gujarat, India

Reference Id:AM - RA 21-22