Officer/ Asst. Manager ( Regulatory Affairs)
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Officer/ Asst. Manager ( Regulatory Affairs)

Dear All,

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

Job Description:

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 surya.g@heterodrugs.com

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