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

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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