HETERO LABS LIMITED – Urgent Openings in Regulatory Affairs | Apply Now
Greeting from Hetero.
We have opening for Regulatory Affairs Officer, Executive, Sr.Executive, AM Position
Department: Regulatory Affairs
Position Officer/Asst. Mgr
Experience: 2 Yrs to 9 Yrs
Job Location: Hyderabad
To verify the country specific guidelines, evaluate & submit the dossiers as per the client/MOH requirements.
To prepare the dossiers (eCTD, CTD & country specific format) that review, organization for US, EU, Canada and regulated markets.
Receipt and submission of responses to the queries of dossier of data packages submitted.
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.
To prepare & submission of post approval changes (PAC) in accordance with country specific variation guidelines & get the approvals.
Keeping abreast with updating of country specific regulations and guidance.
Interested Candidates share profile to [email protected]
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube