Ciron Drugs & Pharmaceuticals - Urgent Openings Officer / Sr. Officer / Executive / Team Leader - Regulatory Affairs - PHARMA WISDOM

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Monday, 27 July 2020

Ciron Drugs & Pharmaceuticals - Urgent Openings Officer / Sr. Officer / Executive / Team Leader - Regulatory Affairs


RA Officers/ Executives /Team leader @ Ciron Drugs and Pharmaceuticals Pvt. Ltd
Job location:  Jogeshwari
Designation:  Officer / Sr. Officer / Executive
Experience:  3years and above
Job Responsibilities:
- Compilation, review and timely submission of error free registration dossiers under CTD/ACTD/Country Specific for International market (CIS, LATAM, AFRICA & ASEAN market).
- Co-ordinate with various cross functional team members as well with various functions within F&D, ADL and manufacturing locations for collecting technical data required towards registrations / MOH / customer deficiencies.
- Keeping up to date with changes in regulatory legislations and guidelines.
- Ensuring compliance with regulations set by the regulatory agencies.
- Ensuring that quality standards are met and submissions meet within stipulated timelines.
- Review of Normative Documents (NDs) of products required towards registration in CIS countries.
- Knowledge about CMC section required for dossier compilation.
- Responsible for compilation & review of quality documents like MMF, RM/FP SPCN, STP, Stability Protocols & Report, Process Validation protocols & reports, Analytical method validations.
- Liaise with marketing for the finalizing the product pipelines and providing required dossiers for submissions. 
- Liasioning with customers for contract manufacturing/loan licensing towards registrations of the products.
- Responsible for preparation of FDA documents for registration of new product, license for new products (proforma), COPP data compilation & verification.
Interested Candidate can send their resumes at  hr.ho@cironpharma.com


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