Team Member

2 weeks ago

Vikhroli Mumbai Maharashtra, India Cipla Full time

**Division**:

- IPD**Department**:
Regulatory Affairs

**Employment Type**:

- Permanent**Job Purpose**:
Compile dossier in accordance with regulatory strategy, manage deficiencies, evaluate products and submit tenders to ensure adherence to regulatory requirement for various regulated/international markets within agreed timelines

**Accountabilities**:

- Compilation and submission of high quality China/Europe/Brazil dossiers, respecting agreed CMC regulatory strategy, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Identify the required documentation for submissions and negotiate the delivery of documents in accordance with project timelines.
- Collecting data from various departments for preparation of dossiers to support the product registration.
- Review and approval of various CMC documents.
- Evaluation, compilation, review and submission of high quality deficiency response during registration and ensuring timely submission of deficiency response.

**Education Qualification**:
Graduate/Post Graduate in Pharmacy or Life Sciences

**Relevant Work Experience**:
Minimum 3-4 years’ experience in China/EU/Brazil/Australia/UK regulatory affairs for drug products (Pre-approval)

**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, Mumbai

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