Cipla Pharma Vacancies – Apply Now for Team Member Role
Team Member – Regional RA
Posting Date: 12 Dec 2024
Country: India
State: Maharashtra
Location: Vikhroli
Req Id: 90291
Division: IPD
Department: IPD
Employment Type: Permanent
Job Purpose
Submit product documents to regulatory authorities in accordance with country-specific regulatory requirements to ensure approvals and market launch in stipulated time. Handle post-approval changes, maintenance, and updating of documents during the product’s life cycle.
Accountabilities
- Achieve timely submission of dossiers/DMF and deficiency responses to regulatory authorities by reviewing, collating, and compiling documents to ensure approvals for launch within the stipulated time.
- Submit post-approval variations for changes to improve productivity, cost-effectiveness, and product quality by reviewing, collating, and compiling the variation application to meet delivery timelines. Maintain Product Marketing Authorization, renewals, and address the Sunset Clause to ensure continuous validity of marketing authorizations.
- Maintain and update product dossiers as required to meet changes in Cipla’s internal systems, regulatory guidelines, and specific regulatory requirements.
- Update the database (PRC/SAP-RA/table) associated with product dossier approvals by including registration details in the database.
- Provide regulatory support throughout the life cycle of the product to ensure smooth functioning.
- Ensure the suitability and availability of dossiers for out-licensing and in-licensing opportunities.
- Communicate with regulatory authorities (EU, NZ & TGA) regarding submission activities and approval statuses for completed submissions.
Education Qualification: B. Pharmacy, M. Pharm, BSc, or MSc
Relevant Work Experience: Minimum 5 years of experience in regulatory activities in the pharmaceutical industry, preferably with expertise in the same region/authority.
Competencies/Skills
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location: Vikhroli
Link to Original Notification to apply: APPLY ONLINE HERE
Keywords: Cipla, Team Member, Regional RA, Pharma Industry, Regulatory Affairs, Vikhroli, Maharashtra, India. Cipla Pharma Vacancies – Apply Now for Team Member Role. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
