Akums Drugs & Pharmaceuticals Ltd – Openings for Executive / Sr. Executive – Regulatory Affairs
Hands on Experience of Regulatory Norms for ROW markets.
Preparing dossiers for ROW market based on ICH CTD / ACTD format as per the country requirement.
Registration of Pharmaceuticals in International markets.
Good knowledge of CTD & ACTD formats.
Well versed with ICH Guidelines.
Responding to queries raised by consultants and MOH of the above regions.
Executive / Sr. Executive- Regulatory Affairs ( ROW) For Mumbai
Experience: 3-6 yrs
Qualification: B.Pharm / M.Pharm
Contact Mail-ID: firstname.lastname@example.org
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