Recruitment & Commercial Head at Future India Services
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Regulatory Consultant (3-6 yrs)
- We are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have been providing high quality & timely consulting service to the Pharmaceutical Industry and have a young, small but committed team of GMP and Regulatory Experts.
- We are inviting applications for the role of Regulatory Consultant. We are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm.
Role & Responsibilities
The person will be an individual contributor and report to Senior Consultant - Regulatory, and will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following :
- Ownership for assigned regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed and Emerging markets
- Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs
- Providing strategic input to the Management and Partners on regulatory projects
- Keep abreast of new developments in regulations across all critical health authorities
Experience & Qualifications :
- Formal regulatory affairs experience for a minimum of 3-6 years. Experience with a consulting company & a previous managerial role would be considered an advantage
- Experience of DCP filing and m1-m5 CTD writting for EU, Australia, Canada
- ANDA writing, review, experience in using eCTD software for publication.
- Computer and technical skills (including eCTD software knowledge)
- Strong & Flawless communication skills.
- Accuracy and attention to detail.