Cipla Regulatory Writing Team Member Job For BPharma & MPharma
Team Member – Regulatory Writing
Posting Date: 15 Oct 2024
Country: India
State: Maharashtra
Location: Vikhroli
Req Id: 89193
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 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. Coordinating 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:
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location: Vikhroli
