Company Information

- 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.

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