The Director/Senior Director of Veterinary Regulatory Affairs will be responsible for overseeing the preparation and submission of regulatory applications, reports, and correspondence related to veterinary products, animal health drugs, and agricultural medicines, specifically within the scope of the FDA’s Center for Veterinary Medicine (CVM). This position will work closely with the FDA-CVM and other regulatory bodies to ensure full compliance with FDA standards for veterinary drugs and animal health products. The role will report directly to the Chief Regulatory Officer.

Reporting to the Vice President, Global Clinical Development & Operations, this role manages multiple clinical studies from Protocol Concept and Development to Clinical Study Reporting and Disclosure. This is an exciting opportunity for an individual with an MD background, proven track record of clinical protocol development, managing studies, internal cross-functional collaboration and coordination, CRO and vendor management to join a dynamic team working to deliver high quality studies on time and within budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and standard operating procedures.

Requirements:

• MD degree from the US or abroad (Medical residency not required and currently not practicing medicine.
• Minimum 10–15 years of experience in the pharmaceutical industry in a senior manager position performing clinical development and operations functions.
• Proven track record including internal cross-functional coordination, CRO and vendor management to deliver high quality studies to time and budget.
• Previous pharma industry experience managing early through late phase studies.
• Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges.
• Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate rapidly changing priorities and deadlines.
• Solid project and vendor management, analytical and problem-solving skills.
• Prior experience with forecasting, tracking and reconciliation of study budgets.
• Prior experience with authoring and coordinating the development of clinical protocols, Investigator brochures and study reports.
• Excellent written and verbal communication skills.

Independently develop, validate, and oversee the performance of testing methods designed to characterize cell-based therapeutic products at various stages of product development. Perform release and stability testing on GMP and non-GMP biologic therapeutic products for both human and veterinary programs.

Requirements:

• A bachelor’s degree in chemistry, biology or a related field, and a minimum of five years of GMP manufacturing and/or GMP laboratory industry experience are required.
• An equivalent combination of a graduate degree and experience sufficient to successfully perform the job duties as listed above is acceptable.

The Associate Director of GMP Manufacturing is a critical leadership role in overseeing all aspects of GMP drug substance and /or drug product manufacturing for Phase 3 clinical and commercial stage programs. This position will report to the Senior Director of GMP Manufacturing at Rion.

Requirements:

The Analytical Development Research Associate will contribute to analytical method development, implementation, and pre-qualification of methods focused on Rion’s exosome technology. This role will work closely with Rion Quality Control to execute method transfers and support continuous improvement. As such, the candidate will possess the technical skills required to conduct experiments and assays in a wet lab environment involving techniques such as mammalian cell culture, ELISA, RT-qPCR, HPLC and colorimetric/fluorometric-based assays. The Analytical Development Research Associate will be responsible for the execution of experiments, as well as data interpretation and final reporting. The position affords the opportunity to serve as a key member of Rion’s scientific team and contribute to the advancement of exosome therapeutics. The Analytical Development Research Associate will work closely with the Analytical Development Scientists and support the efforts of Quality Control/Process Development. As such, the successful candidate will work in an upbeat, highly collaborative and dynamic environment. Additional responsibilities associated with this position will involve assisting in day-to-day laboratory operations such as inventory management, procurement, and general laboratory and equipment maintenance.

Requirements: