Ciron Drugs And Pharmaceuticals Urgent Openings for Regulatory Affairs

Ciron Drugs & Pharmaceuticals – Urgent Openings for Regulatory Affairs

Ciron Drugs And Pharmaceuticals Urgent Openings for Regulatory Affairs

Regulatory Affairs 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  [email protected]

 

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