Join a Regulatory team with deep expertise led by an industry veteran with over 30 years of experience. Over the past several years Veristat has contributed to >10% of the approved US marketing applications. The Team is an incredibly collaborative, experienced group of regulatory professionals, including regulatory focused project management, US and EU strategy, CMC and publishing/submission capabilities. Join the excitement of a rapidly growing team. We are looking for Regulatory CMC experts, who have experienceauthoring key components of module 3 and 2.3 for IND’s, NDA’s AND BLA’s. Work on projects across many disease areas, including oncology, CNS and rare diseases and multiple global companies where you can “make a difference”. Veristat offers flexible schedules, a collaborative work environment, and the opportunity to truly make a difference in the lives of patients.
If you are someone who likes having fun while working, loves good humor and appreciates a family environment in your work world, this is the company to be a part of! We are Respectful, Thoughtful, Agile, United & Innovative!
The Regulatory Chemistry Manufacturing and Controls (CMC) Strategist plays a key role in providing expert consultation to Veristat’s clients, in translating regulatory CMC requirements into practical application to ensure the success of pharmaceutical manufacturing and associated regulatory submissions. S/he will serve on project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of CMC submissions, and create strong rapport with clients.
As a Regulatory CMC Strategist You Will…
Provide consulting services in regulatoryCMC program strategy, overall drug substance and drug product development plans,analytical method development and validation (including methods intended to support nonclinical and clinical studies, such as pharmacokinetic assays), strategic regulatory communications, and FDA representation related to chemistry/manufacturing issues.
Oversee the Regulatory CMCaspects of client projects and project teams through the coordination of internal staff andthird party vendors.
Write, review, and provide strategic guidance related to interactions with health authorities (including, but not limited to US FDA) on all matters related tomanufacturing of drug substance and drug product for development and commercialization.
Coordinate activities when appropriate with assigned Regulatory Strategists supporting clinical and non-clinical development and with publishing team for all CMC related submissions.
Assist in business development efforts by contributing to project proposals.
Prepare clients for CMC topics for FDA meetings, and as contracted, serve as the Health Authority contact person for CMC communications.
Provide strategic and regulatory compliance reviews of documents for marketed products and support post-approval changes, including determination of categorization (i.e. CBE vs. PAS).
Author, direct and provide strategic CMC guidance to regulatory submissions worldwide (IND, NDA, BLA, MAA, PMA, IMPD/CTA; both original applications and amendments) with support from management as needed.
Provide peer review forModule 3, the Quality Overall Summary,bioanalytical and analytical method reports for human and animal studies, CMC sections of briefing books and Investigator’s brochures and other development documents as required with support from management as needed.
Prepare and present at internal and client meetings as needed to provide regulatory CMC guidance.
Provide a high standard of customer service and ensure complete understanding of Veristat’s offerings and responsibilities.
Experience + Requirements
Bachelor’s degree in a related field required. Advanced scientific degree (i.e.PhD or Master’s degree) preferred.
10years of relevant chemistry/manufacturing/analytical experience with at least 5years of relevant regulatory CMC experience in a clinical research organization and/or pharmaceutical development setting required (or demonstrated ability to function at this level), with a proven track record of global regulatory submissions, and strong relationships with the regulatory agencies.
Knowledge of at least one type of pharmaceutical product (i.e. small molecule, biologic and cell/gene therapy), with a strong preference for 2 or more types.
Extensive experience with at least one formulation/route of administration (i.e. oral, injectable, sublingual, transdermal, inhaled) with a strong preference for extensive knowledge of two or more routes/formulations.
Thorough knowledge of International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines as well as of CMCterminology, contract manufacturing, and pharmaceutical product development.
Experience serving as an interface with Health Authorities required, with a demonstrated ability to integrate scientific and business objectives to ensure a positive commercial outcome from health authority negotiations.
Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with manufacturing, specifications, analytical testing and overall regulatory CMC requirements that apply to Phase I-III clinical developmentand post-approval changes are required.
Demonstrated ability to develop and foster positive client relationships.
Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
We help you overcome all the difficult challenges that arise during clinical development, regulatory approval, and post-marketing surveillance.
Veristat is a scientific-minded global clinical research organization (CRO) that will guide you through the complexities of the clinical development and regulatory submission process. We impart strategic decision-making and operational support for your clinical trials and regulatory submission projects by truly creative, innovative, and scientific thinkers. There is no "one size fits all" approach to clinical research. Our teams partner with you to understand your goals to plan and execute your clinical program to achieve success. And, we truly want to make a difference to help you get your medical therapy to market to improve or save people's lives.
In 2020, Veristat teams supported marketing applications for 10% of all FDA Novel Drug Approvals.