Officer/ Asst. Manager ( Regulatory Affairs)

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

You Got This — Apply

You're almost there! It's just a few steps between you and job glory. For uploads, please use .pdf, .doc or .docx files. Employers recommend using .pdf.

By applying to this job, you agree to The Pharma Revolution Terms of Use and Privacy Policy.