Roles and Responsibilities
- Preparation, compilation, reviews of ANDA.
- Timely submission of dossier to the USFDA in electronic format (eCTD) and the subsequent life cycle management.
- Review all regulatory submission materials to ensure timeliness, accuracy, comprehensiveness or compliance with regulatory standards.
- Publishing of various Electronic Submissions for US FDA (eCTD Submissions).
- Management of documents in the electronic document management system throughout their life cycle.
- Working with Regulatory Publishers in Regulatory Operations to ensure the Modules in electronic document management system are as per regulatory guidelines.
- Ensuring compliance with regulations set by the USFDA. Gathering, evaluating, organizing, managing and collating information in a variety of formats.
- Keeping up to date with changes in regulatory legislation and guidelines.
- Liaising and negotiating with regulatory authorities.
- Preparing documentation.
- Job role is Not limited to above
Desired Candidate Profile
- Required Experience: 5+ Years
- Position Based at: Ankleshwar, Gujarat
Salary: Not Disclosed by Recruiter
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Desired Candidate Profile
ZCL CHEMICALS LTD
Dear Candidate :
We are USFDA, WHO GMP, ISO 9001, ISO 14001 and OHSAS 18001 certified Company. ZCL Chemicals Ltd.(formerly known as Zandu Chemicals Ltd.) was founded in 1991.
ZCL is engaged in manufacturing Chemical Intermediates and Active 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 fine chemical 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.
We are looking for passionate team members to contribute and achieve individual and organizational success. you can also send your Cv on Hrd@zclchemcials.com
Contact Company:ZCL CHEMICALS LTD
Address :ZCL CHEMICALS LTD Plot No. - 3102/B, | G.I.D.C. | Ankleshwar(E), BHARUCH, Gujarat, India
Reference Id:RA -2020