
Team Member
10 hours ago
**Division**:
- IPD**Department**:
- IPD**Employment Type**:
- Permanent**Job Purpose**:
Provide support to RA by preparing regulatory medical writing documents for dossier filing and renewal
**Accountabilities**:
I. Preparation of medical writing documents to support of product registration and life cycle globally except for India
II. Provide insights to RA team to support European, WHO, MCC and US regulatory strategy (biowaivers, posology and proposed indication) by comparing country specific product information/guidance
III. Prepare documents as a response to global regulatory/customer queries on submitted dossiers, scientific justification, bio-waiver justifications and regulatory strategy documents
IV. Co-ordinating with cross-functional teams (BD, packaging, RA, PV etc) to reduce query cycle time and improve document quality
**Education Qualification**:
Bachelor’s / Master’s degree in Pharmacy
**Relevant Work Experience**:
1-4 years of experience in the field of regulatory medical writing
**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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