="text-align: center;">Pharma Jobs at Cipla – Recruitment For Team Members
At Cipla, we are committed to making a difference in the lives of patients. As a leading pharmaceutical company, we strive to provide high-quality and affordable medications to people around the world.
Job Posting: Team Member – Regional RA (79685)
Requisition ID: 79685
Posted: 09/10/2023
Location: India – Maharashtra – Vikhroli
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 and handle post-approval changes, maintenance, and updation of documents during the product’s life-cycle
Accountabilities
- Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
- Submit post approval variations for changes that improve productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisations.
- Maintain and update product dossier as required to meet changes in Cipla’s internal systems, changes in regulatory guidelines, and to meet the need of 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 for smooth functioning
- Provide the information and availability of dossier for out-licensing and in-licensing
- Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done
Education Qualification: B.Pharmacy, M. Pharm, Bsc or MSc
Relevant Work Experience
Minimum 5 years’ experience in regulatory activity in the pharma industry preferably worked for the same region/authority
Competencies/Skills
- Communication Skills (clarity of thought, comprehension)
- Likely potential for growth
- Job / Product / Technical Knowledge / Pharma domain knowledge
- Presentation & Interpersonal skills (If applicable)
- Managerial or People Management skills
- Safety awareness (If applicable)
- Relevance of Previous Experience
- Comprehension, Analytical & Problem-solving abilities
- Productivity & Result Orientation (If applicable)
- Attitude
- Qualification fitment
- Sales drive (If applicable)
- Personality traits (Individualistic / Team player, Outspoken, Maturity level etc.)
Job Location: Vikhroli
Keywords: Pharma Jobs, Cipla, Recruitment, Team Member, Regional RA, Pharma Industry, Regulatory Activity, Maharashtra, Vikhroli
Link to Original Notification to apply: Click here
