Cipla Job Vacancy for IPD Department
Requisition ID 69026 -
Posted 29/08/2022 - India - Maharashtra - Mumbai
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 products life-cycle
Accountabilities
I. 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
II. Submit post approval variations for changes that improves 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.
III. 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
IV. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
V. Provide Regulatory support throughout the life cycle of the product for smooth functioning
VI. Provide the informatuitability and availability of dossier for out-licensing and in-licensing
VII. 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 pharma industry preferably worked for 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, Out spoken, Maturity level etc.)
Job Location
Mumbai
Post a Comment