Xeris is actively searching for a Director of Regulatory CMC to join our team in San Diego, CA. Responsible for leading the CMC regulatory function, the Director, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing of regulatory CMC submissions and manage the interactions with all Health Authorities for CMC topics. This individual will provide CMC regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
Serve as the lead liaison between our company and regulatory bodies for CMC related questions
Responsible for aiding in the coordination, authorship, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submission and marketing applications to FDA and international regulatory authorities), which support clinical programs, CMC and quality.
Provides quality/CMC review for clinical study protocols, clinical study reports, investigator brochures and other relevant reports.
Ensure continued management, development and process improvement of CMC related activities within the organization in response to agency feedback or changes in the regulatory environment.
Support GMP audits at manufacturing and distribution facilities.
Develops and communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle.
Lead/participate in meetings with internal stakeholders and external business partners or teams, in order to communicate regulatory CMC guidance and strategies
Ph.D. or a Master’s degree with 10+ years pharmaceutical industry experience and a minimum of 8 years in Regulatory Affairs.
Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
Established working knowledge of regulatory guidelines and regulations (US and international).
Regulatory experience supporting both development projects and commercial products.
Strong knowledge of eCTD elements and structure and regulatory writing skills.
Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
Strong communication skills both written and oral.
Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Professional demeanor and an excellent written and verbal communicator.
Detail oriented and well organized.
Good and thoughtful listener.
Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
Up to 50% travel required, including some international travel
Internal Number: 001
About Xeris Pharmaceuticals
Xeris is a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use, liquid-stable injectables. The company’s proprietary XeriSol™ and XeriJect™ formulation technologies allow for the subcutaneous (SC) and intramuscular (IM) delivery of highly concentrated, non-aqueous, ready-to-use formulations of peptides, proteins, antibodies, and small molecules using syringes, auto-injectors, multi-dose pens, and infusion pumps. Xeris’ platforms have the potential to offer distinct advantages over existing formulations of marketed and development-stage products. In particular, XeriSol™ and XeriJect™ offer the opportunity to eliminate reconstitution, enable long-term room temperature stability, significantly reduce injection volume, and eliminate the requirement for intravenous (IV) infusion. These attributes can lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system