Job Description

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 Ciplaa?Aa,Aa,Aa?Aa,Aa,Aa?Aa,Aa,Aa?Aa,Aa,Aa?Aa,Aa,Aa?Aa,Aa,As 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 yearsaAEURA(TM) 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

Vikhroli

Shift Hours