Pre Approval Jobs – Apply to Latest Pre Approval Job Vacancies

Regulatory Affairs - Manager / Deputy Manager AET Laboratories

10 - 15 years

13 - 15 Lacs

Hyderabad

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Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Posted 1 month ago

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Regulatory Affairs Associate - Europe Market Aurobindo Pharma

3 - 8 years

3 - 8 Lacs

Hyderabad

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Role & responsibilities Post Approval Pre Approval Dossier Compilation Life Cycle Management Preferred candidate profile Europe Market

Posted 2 months ago

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Asst. Manager- RA (Regulatory Affairs) -Formulation Pharma - Bangalore BVR People Consulting

4 - 8 years

5 - 13 Lacs

Bengaluru

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Greetings from BVR People Consulting!! Position: Regulatory Affairs - Formulation Designation: Executive or Asst. Manager Division: Injectable and Solid oral products Qualification: B. Pharm, M. Pharm and M. Sc (FULL TIME) only Years of Experience: 4 to 8 Years CTC range: 5 to 13 LPA. Job Locations: Bangalore ( Electronic City ) No. of Positions: 04 Job Summary: Compilation and submission of the dossier and query responses as per the EU/UK/ANZ /Israel/Belarus and Ukraine regulatory requirements within stipulated timeframe (for Injectable and Solid oral products ). Interaction with CFTs for product specific requirements and to attend product strategy meetings. Review of final data and technical documents received towards dossier compilation from API team, RnD, IP, PV, QA, Commercial, Packaging and Plant team. Compilation of labelling documents as per current EU/UK/ANZ/Israel/Belarus and Ukraine regulatory requirements. eCTD Publishing of dossiers in DocuBridge software. Product life cycle management for approved Europe products i.e. variation, Renewal and sunset exemption filings. Maintain product database, regulatory files, records and reporting systems. Timely updation and maintenance of RIMS database. Preparation and submission of high-quality national translations for National Phase. Post Approval and Pre approval NOTE: We are looking Notice period 01 month or immediate joiner. Interested Candidates should forward their resume to " ganapathi@bvrpc.com" and also Your Current CTC, Excepted CTC and Notice period. Thanks K Ganapathi Mob. No. 9600387468

Posted 3 months ago

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