Manager/Assistant Manager - Regulatory Affairs
MNC looking for Regulatory Affairs Manager
Attractive compensation and great work life balance
About Our Client
Our client is one of the Top 20 Global Pharmaceutical Companies. The organization has entered India recently and is looking to launch new pharmaceutical molecules in the country in the near future. They are looking to hire someone who will lead the Regulatory Affairs based in Delhi.
Reporting to the Regional Regulatory Affairs Director based out of Singapore, you will be responsible for
To apply and obtain approval for registration of new product, new indication, renewal of license, and supplemental change in a timely manner.
Window person with CDSCO, DP, NPPA and external regulatory consultant on drug safety and new regulations concerning drug administration.
To prepare dossiers for required regulatory actions with close collaboration with stakeholders of AID, API & SESA
- To be involved in the dealings with the registration authorities at the top level and to get the products registered.
- To validate the pharmaceutical dossiers of the existing products
The Successful Applicant
the successful candidate comes with:
- Working knowledge on regulatory environment of Indian pharmaceutical industry.
- Good knowledge about Indian regulations on new drug registration.
- Good knowledge about Indian drug administration laws and enforcement laws.
- Good English for communicate with Global/ Regional Colleagues
- University graduate and master majored in natural science, medicine, pharmacology.
- Working experience in the industry for minimum of 10 years
- Experience in registration of new drugs at least 5 years
- Experience in new product registration
- Experience in preparation of dossier for new chemical entities and new formulations.
What's on Offer
* Attractive compensation and great work life balance
* Opportunity to work with Leading Pharmaceutical MNC