Job Description

Division

IPD

Department

IPD

Employment Type

Permanent

Job Purpose

Prepare, review, ,modify, collate, submit documents for product registrations and maintain life cycle of respiratory products, update regulatory database, support launches and ongoing commercials to meet the objectives of regulatory affairs sub-function

Accountabilities

I. Check region-wise regulatory requirements, perform gap analysis for registered dossiers, compile/recommend regulatory strategy for product submission to check leveragability, and to support development activities
II. Compile respiratory product dossiers by collating and reviewing relevant registration information, submit dossiers as applicable, compile deficiency responses to facilitate timely approvals of respiratory products globally
III. Support on-time launches and ongoing commercials of respiratory products and devices identified by the business plan through cross functional co-ordination and review of documents to ensure launch within timeline
IV. Update and provide the regulatory status of respiratory products for maintenance of the global registration database
V. Manage post-approval life cycle management by contributing to the closure of change controls, by compiling and submitting regulatory packages, relevant to life cycle management to
VI. Support portfolio initiatives eg. identifying leverage products by evaluation of data, compliance with respect to site transfer initiatives to
VII. Participating in Control Tower, SAP, CIPDOX, GOOSE, meetings on behalf of respiratory team

Education Qualification

Bachelor's / Master's degree in Pharmacy

Relevant Work Experience

6yearsaAEURA(TM) experience in regulatory filing (compilation, submission and approval) with knowledge of drug product development and respiratory products (for US/EU/International markets)

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