Officer/ Asst. Manager ( Regulatory Affairs)
Greeting from Hetero.
We have opening for Regulatory Affairs Officer, Executive, Sr.Executive, AM Position
Department: Regulatory Affairs
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, an organization for US, EU, Canada, and regulated markets.
3. Receipt and submission of responses to the queries of a dossier of data packages submitted.
4. To co-ordinate with cross-functional teams to initiate the new studies to 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.
Note: Interested Candidates share profile to firstname.lastname@example.org