Greeting from Hetero Biopharma.
We have an opening for Regulatory Affairs Position
Department: Regulatory Affairs
Designation: Sr.Executive /Asst.Manager
Experience: 4 Yrs. to 8 Yrs.
Job Location: Jadcherla(Telangana)
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 AFRICAN, CIS, LATAM and MENA region countries.
3. Receipt and submission of responses to the queries of dossier of data packages submitted to AFRICAN, CIS, LATAM and MENA countries.
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.
7. To co-ordinate with CFTs for preparation of Master Artworks.
Interested Candidates share profile to firstname.lastname@example.org
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Employment Type:Full Time, Permanent
PG:Any Postgraduate in Any Specialization
Hetero Drugs Limited
Contact Company:Hetero Drugs Limited
Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath , Nagar, Hyderabad, Telangana, India