Exe./ Sr. Executive- Regulatory Affairs- Pharma (ROW), Navi Mumbai.

3.00 to 5.00 Years Navi Mumbai 14 Feb, 2023

Job Location	Navi Mumbai
Education	Not Mentioned
Salary	Not Disclosed
Industry	Pharma / Biotech
Functional Area	General / Other Software
EmploymentType	Full-time

Job Description

Candidate will based at Mumbai.You will be responsible for,1. Candidate will be responsible for Preparation & review of product registration/renewal of dossiers (CTC/ACTD) for Asian & African countries (ROW).2. Candidate will be responsible for heading the RA Dept. activities with respect to dossierpreparation for registration/renewal of registration, manufacturing license with products, WHO-GMP Certificate, MSO registration, etc.3. Candidate will be responsible for to obtain additional product permissions, test license,certificates, export NOCs from CDSCO, COPPs, plan approvals, technical staff registration andapproval, public testing labs approval, etc.4. Candidate will be responsible for to submit the required information to regulatory authorities.5. Candidate will be responsible for Obtain product permissions, test license, plan approval, etc.Required Candidate profile1. Candidate is B.Pharma / M. Pharm / M.Sc with minimum 3 to 5 years experience in reputedPharma Formulation and candidates should have experience in Handling Regulatory Affairs forROW Market.2. Preparation & review of product registration/renewal of dossiers (CTC/ACTD) for Asian & African countries (ROW).3. To ensure regulatory compliance as per D&C Act and Marketing authorizations.4. To check the artworks for compliance with regulatory and pharmacopoeia requirements ofproducts.5. To ensure regulatory compliance as per D&C Act and Marketing authorizations.,

Keyskills :
lean manufacturingpreparationregistrationcontinuous improvement facilitationregulatory affairsroot cause analysis

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Exe./ Sr. Executive- Regulatory Affairs- Pharma (ROW), Navi Mumbai.

Job Description

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