Vacancy for Regulatory Affair Executive at Oracity Life Sciences

Oracity Life Sciences was focusing on solid oral dosage forms (Tablets / capsules) with immediate as well as modified release technology. We will be catering Granules for immediate release, modified release tablets, different range of pellets formulation ready to encapsulate, MUPS ready to compress along with finished dose formulation of tablets and capsules. We have designed the facility / systems to meet all regulatory standards (like WHO, MHRA, USFDA etc…) and will be catering to domestic, ROW and highly regulated market.

Post : Regulatory Affair Executive - 03 posts

Job Responsibilities & Required Skills
• Compiling & Filing the Common Technical Documents (CTD) for markets like Asian countries & ROW Market.
• Compiling & Filing the Dossiers & Drug Master Files of country.
• Follow up with Regulatory Affairs Department for timely submission of dossier.
• Review of dossier received from Regulatory Affairs Department prior to MOH / Customer submission.
• Handling technical queries received from agents and Health Authorities of respective countries for registration of products.
• Good knowledge about guideline like- ICH, ASEAN and ROW.
• Review and checking of plant Specification, BMR, raw material COAs and other documents of loan license products as per customer registered documents and sharing the same with loan license customer as per requirements.
• Coordination with different department for timely completion of assignments.
• Internal audit of R & D department for availability of documents as per regulatory requirements.

Candidate Profile
B.Pharm, M.Pharm, with minimum 1 years of cumulative experience in the Regulatory Affair department in Pharmaceutical Industry.

Additional Information
Experience : 1 year
Qualification : B.Pharm, M.Pharm
Location : Butibori Nagpur
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affair
End Date : 5th April, 2020