Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.
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
1. Communication Skills (clarity of thought, comprehension)
2. Likely potential for growth
3. Job / Product / Technical Knowledge / Pharma domain knowledge
4. Presentation & Interpersonal skills (If applicable)
5. Managerial or People Management skills
6. Safety awareness (If applicable)
7. Relevance of Previous Experience
8. Comprehension, Analytical & Problem solving abilities
9. Productivity & Result Orientation (If applicable)
10. Attitude
11. Qualification fitment
12. Sales drive (If applicable)
13. Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
Job Location: Vikhroli
Shift Hours
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