By admin We at Meril expanding our Regulatory Affairs team for multiple roles:
Job Description:
1. Devising regulatory CMC strategy and planning the submission for various biological products (biosimilars), new drugs, & post approval variations (BLA, CTA, IMPD, IND, & MA) especially the early phase of product development experience with RCGM application.
2. Prepare the application for import of new drugs, dual NOC, test license for examination, test anand analysis and clinical trials.
3. Review and compilation of CMC data to appropriate standards & requirements to the various markets.
4. Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations.
5. Support CMC regulatory risk assessments and drives contingency planning and mitigation of identified regulatory risks.
6. Evaluation of internal documents for regulatory compliance and gap analysis.
7. Preparation, review and compilation of responses to regulatory queries.
8. Preparation / review of registration dossiers and variations / amendments / annual reports / renewals as applicable.
9. Authoring and reviewing the biological regulatory submissions by gathering the data.
10. Strong in national regulatory, ICH, and FDA guidelines, regulations, and monographs, analyzing technological advances and industry trend to advise the team in updated regulations.
11. Coordinating and tracking of regulatory activities involved with internal departments.
Requirements:
1. M.Sc / M.Tech / M.Pharm any life-science disciplines with minimum 2-3 years and 6-10 years of experience in any biologics / biosimilars regulatory sciences.
2. Previous experience in process and analytical development, or biologics manufacturing will be an added advantage.
3. Proven record of successful authoring and contribution to delivering CMC sections of marketing authorizations for biologics.
4. Knowledge of cGMP requirements and standard systems (e.g. change management systems and QMS tools)
5. Authoring and re-authoring IMPD/INDs and Module 3 for biologics.
Sound understanding of ICH and major markets’ regulations on biologics.
6. Collaborate with R&D, Manufacturing, QA, QC and other functions.
If you feel you are the right fit, pls reach out to ramesh.m@microcrispr.com
Location: Vapi, Gujarat.