Serán BioScience aims to expand client services by adding a Regulatory Affairs/Audits Program Manager to our skilled Quality Assurance group. The primary goals will be supporting regulatory submission needs for Serán’s clients as well as supporting Serán’s internal and external audit program. This role will be responsible for the development, compilation, maintenance, and review of regulatory submissions for clinical IND and NDA/BLA applications related to Module 3 (CMC). Additionally, the Regulatory Affairs/Audits Program Manager will provide training to Serán staff in preparation for health authority inspections, represent Regulatory Affairs on project teams, participate in development teams, determine regulatory strategy for implementing commercial facility start-up activities, and interface with external clients/contractors/consultants.

This key role will develop and implement regulatory strategies leading to successful registration and life-cycle management of complex products serving patients and clients. This position builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.

Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs. Serán fully funds employees and their household with dental, vision and one medical plan option. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with pet programs as well.