RA Officers, Executives, Team leader vacancies at Ciron Drugs & Pharmaceuticals

More than 150 satisfied customers in 50 countries across the globe. Catering to client requirements in terms of offering wide range of customized generic and/or branded formulations. Wide basket of products across therapeutic areas and formulations – Lyophilized and Liquid Injectables ophthalmics, Externals, Liquid orals and Oral solid dosage forms. Strong back up of technically qualified R&D team for new formulation development as per individual client and market requirements. State of art WHO-GMP facilities to cater to your manufacturing requirements.

Post : RA Officers / Executives / Team leader

Job location : Jogeshwari, Mumbai

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.