Director, Regulatory Affairs - Lupin Pharmaceuticals (Company Headquarters) (baltimore, maryland)
Posted: Friday, April 14, 2017 1:14 AM
The candidate will work with various teams in LUPIN during early stages of product development to assure the high quality of regulatory submissions, review of submissions which are already with the US Regulatory Agency to proactively identify gaps and collaboratively resolve them to affect a faster approval. The candidate is expected to have in depth knowledge related to current FDA regulatory and quality related requirements for ANDAs, Type II DMFs for APIs, 505b(2) and 505b(1) NDA submissions and INDs. The candidate should have a PhD or MS with 5: 10 years of experience working with or for regulatory agencies. This position supervises regulatory personnel as required. Further, it supports all the Regulatory aspects of the CompanyA?s brand and the generic businesses.Work as a part of the Regulatory Affairs Team, with various groups within and outside Lupin (if needed) regarding strategies related to expediting approvals of ANDA and adequacy of Type II DMF submissions.Responsibility will involve extensive and detailed reviewing the Chemistry and Manufacturing Controls sections of ANDAs which are already submitted or are being prepared for submission to the US regulatory agencyResponsible for working closely with Research and Development and other teams within Lupin during the early stages of development of API and finished dosage form, to assure that the API and product related risks are identified and preferably addressed in the original submissions.Work as a part of the Regulatory Affairs Team of Lupin in development of strategies related to 505b(2) submissions, including preparation for FDA meetings, compilation/review of INDs and NDAs.Responsible for providing strategies based on regulatory and scientific perspective for responses to deficiency letters/queries from FDA on pending applications including ANDAs, DMFs, INDs and NDAs. Responsible for preparation of information and related activities for meetings with drug regulatory agencies as well conduct of meeting and preparation of accurate meeting minutes, if neededProvide support for due diligence activities associated with business development as requiredMaintains a detailed knowledge of FDA regulations, guidelines and standard proceduresResponsible the preparation the preparation of periodic (monthly, quarterly, annual) progress reports as requiredPerform other duties as assigned.MS or PhD in physical, pharmaceutical, biological or other life science and experience with submissions to the US and other regulatory agencies. Advanced degree a plus. Knowledgeable of FDA review process About 5: 10 years of research in pharmaceutical development and regulatory experience, preferably working with FDA or with submissions to FDAExperience with a successful submissions and approvals of NDA and ANDA applications to the FDA. A history of interaction with the OGD and preferably with New Drug Divisions of the FDA.Background in development of complex generics.Experience with working on INDs and 505b(2) applications.Excellent written and verbal communication skills are required, as well as experience working as part of cross:functional, multinational teams.
• Location: Baltimore
• Post ID: 20984498 baltimore