AddressRole & Responsibilities:
The person will be responsible for project specific regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following:
- Complete ownership for all 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 8 years. Experience with a consulting company & a previous managerial role would be considered an advantage
- Experience with 505(b)(2) and 505(j) ANDA writing, ANDS submissions and approvals, experience in using eCTD software for publication.
- Experience in DCP filing and m1-m5 CTD writing for EU, Australia, Canada
- Computer and technical skills (including eCTD software knowledge)
- Strong & Flawless communication skills.
- Accuracy and attention to detail.
Location: Navi Mumbai
