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

4 - 8 years

5 - 13 Lacs

Bengaluru

Posted:3 months ago| Platform: Naukri logo

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Skills Required

Regulatory Affairs Compilation Pre approval ANZ Ectd Cftc UK Formulation CMC Product Data Management Post Market Surveillance Submission Europe Ukraine Documentation Labels Belarus MHRA RA New Zealand EU USFDA Injectables Israel Product Life Cycle Management

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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www.bvrpeopleconsulting.com

Human Resources Consulting

Anytown

50 Employees

137 Jobs

    Key People

  • Jane Doe

    Founder & CEO

  • John Smith

    Senior Consultant

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