Greeting from Hetero.
We have opening for Regulatory Affairs Officer, Executive, Sr.Executive, AM Position
Department: Regulatory Affairs
Designation: Officer/Asst. Mgr
Experience: 2 Yrs to 9 Yrs
Job Location: Hyderabad
1. To verify the country specific guidelines, evaluate & submit the dossiers as per the client/MOH requirements.
2. To prepare the dossiers (eCTD, CTD & country specific format) that review, organization for US, EU, Canada and regulated markets.
3. Receipt and submission of responses to the queries of dossier of data packages submitted.
4. To co-ordinate with cross functional teams to initiate the new studies for suffice the query response & dossier requirement towards country specific requirements for product registration.
5. To prepare & submission of post approval changes (PAC) in accordance with country specific variation guidelines & get the approvals.
6. Keeping abreast with updating of country specific regulations and guidance.
Interested Candidates share profile to [email protected]