Cipla Ltd B Pharma Team Member – Regulatory Writing job, M Pharma job opening 2023, Pharma job opening 2023, Cipla ltd job opening 2023, Regulatory Writing job opening 2023, Intrested and eligible candidates may check out all the details on the same below:
Job Title: Team Member – Regulatory Writing (78805)
Job Location Vikhroli
Division IPD
Department IPD
Employment Type Permanent
Eligbility Criteria: 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 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/guidanceIII. 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
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