Ciron Drugs Hiring RA Officers/Executives for Jogeshwari location

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.

Email resume to : hr.ho@cironpharma.com

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