Manager Regulatory Affairs Mystic Pharmaceuticals
THIS JOB HAS EXPIRED This person will be part of the product development team working with engineering and quality professionals to insure products in the pipeline are in compliance with applicable regulatory requirements. This person will be responsible for leadership and management of FDA/EMEA regulatory filings and clinical trials for Mystics drug pipeline and drug delivery systems. He or she will direct and manage protocol development, study conduct and data interpretation, and will interact with Mystic partners, study sites (e.g. principal investigators), vendors (e.g. CROs), and other departments within Mystic to coordinate required studies, prepare and submit FDA/EMEA regulatory filings.
Other responsibilites will include:
Regulatory strategy planning for new medical device products. A working knowledge of general medicine and drug therapy including pharmacology, toxicology, trial methodology and clinical pharmacology and an understanding of scientific principles for controlled trials and regulatory requirements for IND/NDA/ANDA submission is essential.
The ability to identify, negotiate and manage CROs or principal investigators and monitoring for adherence to protocol and budget is required. Professionalism and attention to detail is essential, as is willingness to work in a team.
Review and approve quality system documents.
Write and update regulatory SOPs, policies and work practices.
Collaborate with Quality Assurance to manage programs and ensure regulatory compliance with product development, validation, and commercialization activities subject to regulations established by US, EMEA, and other worldwide governments.
Review documentation provided by clients, preparing a gap analysis and writing or supervising the writing of documentation to fill those gaps from IND applications to the FDA and CTA applications internationally.
BS degree in life sciences or related scientific discipline, An advanced degree in Pharmaceutical Sciences or relevant discipline is preferred.
Minimum 7-12 years regulatory experience with compliance related activities required.
Working knowledge of GCP/GMP/GTP/GLP/QSRs.
Ability to manage regulatory projects from regulatory strategy to submission taking into consideration all regulatory requirements, client expectations and project timelines.
A proven record of direct experience with face to face interactions with the FDA and DMF preparation and submission is required. RAC designation is required.
Working knowledge of Quality by Design and Risk Management philosophies as applicable to advanced clinical development of biologics and pharmaceuticals.
||2006A Windy Terrace |
Cedar Park, TX 78613
THIS JOB HAS EXPIRED