M. J. Biopharm Pvt Ltd Hiring 2022 M.Sc/B.Pharm/M.Pharm for Executive/Senior Executive in Regulatory Affairs At Nariman Point . M. J. Biopharm Pvt Ltd Notification full details below..Interested and eligible candidates can Send Resume.
- Vacancy details:
- Post Name: Executive/Senior Executive in Regulatory Affairs
- Qualification: M.Sc/B.Pharm/M.Pharm
- Experienced:03 t0 6 years
- Openings:NA
- Salary:₹ 3,00,000 – 5,50,000 P.A.
Job Description: M. J. Biopharm Pvt Ltd Hiring For Executive/Senior Executive in Regulatory Affairs ! Handling & Knowledge of Granulation, Compression or Coating areas Activities.
- Important Details :
- Location: Nariman Point
- Contact: 9619744167.
- Note:Interested applicant can send their CV on shital@mjbiopharm.com
- Post of date: 04/04/2022
- Selection Process: The selection will be on the basis of Interview.
Job Description:
- Project Management for life-cycle of regulatory submissions
- Preparation and Submission of the Dossiers as per CTD/ACTD/Country Specific guidelines as per assigned timelines
- Understanding of ICH guidelines
- Review and approval of artworks as per the Regulatory requirements.
- Responding to queries raised by regulatory authorities or customers
- Inter Department coordination to arrange documents and samples for Regulatory Submission. Review of documents before adding to dossier.
- Preparation of documents for application for Brand Approval, COPP and country specific FSC.
- Preparation of Custom Clearance Documents for Dossier and sample dispatch to client or authority country specific.
- Preparation of documents for domestic and international tenders
- Archival of Data and Preparation of Compliance Dossier post Registration.
- Opportunity to work on the Sponsor-side of Clinical Trial Management (involves working with a CRO)
Essential Qualifications/Skills
- MSc/BPharm/MPharm candidates with relevant experience may apply
- Exposure to Oral Solids and Injectables strongly preferred
- Very good written and oral English Language skills
- Very good project management, organization and time-management skills
- Positive attitude
- Experience with biosimilars is an advantage.
About Company:
A fully integrated pharmaceutical company engaged in the manufacturing, marketing and distribution of Active Pharmaceutical Ingredients, pharmaceutical formulations and medicinal products across the globe.
