Team Member

2 weeks ago

Vikhroli Mumbai Maharashtra, India Cipla Full time

**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**:
6years' 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**:

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