Rusan Pharma is a pharmaceutical company focused on research, with manufacturing units located in India. We specialize in the worldwide marketing of pharmaceutical formulations, active pharmaceutical ingredients, and intermediates. Our state-of-the-art Research & Development center is situated in Kandivli (west), Mumbai. Additionally, we have a cutting-edge bulk manufacturing plant in Ankleshwar and formulation plants in Dehradun and SEZ, Kandla. It is worth noting that our facilities have received approvals from prestigious health authorities such as MHRA (UK), MCC (SA), and other international organizations.
Rusan Pharma conducting walk-in interview for M.Sc./ B Pharm/ M Pharm candidates in Regulatory Affairs on 1st June 2024.
Department: Regulatory Affairs (formulation)
Designation: Executive
Preferred candidate profile
- Desired Skills (MS Office / Excel/ DOSSIER PREPARATION IN CTD & ATCD/query execution after discussion with seniors & basic email etiquettes and communication skill etc.)
- Desired Experience: Minimum 2 Years & Maximum 5 Years
- Qualification: M.Sc./ B Pharm/ M Pharm
Work Location: Mumbai Suburban
Role & responsibilities
- Preparation and Submission of the dossiers in CTD and ACTD structure.
- Preparation and Submission of the Re-registration dossiers wrt the normative documents (ND) from MOH.
- Communication with manufacturing site for document requirement for dossier preparation. Collection, review and collating the data required for regulatory submissions.
- Arranging sample for registration from sites.
- Preparation of COPP/FSC etc. as per registration requirements.
- Handling the queries of the respective markets sent by local representatives OR the regulatory body of that country in guidance of respective managers.
- Checking Artworks as per the country specific requirements.
- Preparation of Package insert, SmPC, PIL of Generics with respect to Innovator information.
- Responding to request from Internal teams like marketing Domestic and International marketing.
- Maintaining tracker sheets for regulatory status (Registration, submission and targeted submission, etc) updated up to the date.
- Knowledge of submission of SND/ND/CT applications on CDSCO portal will be an added advantage.
- Providing Administrative, Technical and Regulatory Information for compilation of Tender documents to marketing team of Rusan Pharma Ltd.
Walk-in interview details
Date & Time: 1st June , 9.30 AM – 5.30 PM
Venue: Rusan Pharma (corporate office) 58-D, Government Industrial Estate Charkop, Kandivali (West), Mumbai – 400067.
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