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.
Duties and ResponsibilitiesPlans, prepares, and manages submissions to Health Authorities (HAs), including INDs, and NDA/BLA regulatory filings in strong collaboration with clients.Participates in regulatory interactions and inspections including managing preparation of briefing materials for HA meetings/inspections, preparing subject matter experts (SMEs), and ensuring appropriate follow-up/responses.Supports company external, internal, and supplier audit program.Participates in negotiations with regulatory agencies to resolve and review issues, shepherds proactive interactions with regulators.Independently provides effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for projects.Determines regulatory strategy for implementing site commercial facility start-up activities.Utilizes various electronic systems for dossier creation and tracking, as required.Represents the regulatory function on cross-functional product development teams and provides innovative strategic and tactical advice to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.Effectively communicates the regulatory strategy, risks, mitigations, and overall plans to Regulatory Affairs, program teams, and senior management, as relevant.Prepares and manages company's regulatory registrations and/or licenses (e.g. FDA, Oregon Board of Pharmacy).Identifies, communicates, and proposes resolutions to both routine and complex issues.Remains current on Regulatory Intelligence, new guidance documents, and competitive information to provide comprehensive information to program teams.Supports or leads non-project activities, as needed such as SOP/policy development.Performs other related duties as assigned.Preferred and Required Skills and AbilitiesExperience with drug substance and drug products is desired.Knowledge of regulatory requirements across development stages and post-approval is essential.Experience with regulations for small molecules is required.Experience with regulations for combination products is desired.Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.Strong strategic and analytical abilities, diplomacy, and negotiation skills.Demonstrated ability to collaborate and work in cross-functional teams.Strong organizational skills and attention to detail.Ability to collaboratively influence across multiple functions and motivate others to accomplish company objectives.Ability to exhibit flexibility within tight timelines and with strong project management skills.Self-motivated and detail-oriented with sound judgement and innovative thinking to deal with challenges and opportunities.Ability to function well in a high-paced and at times stressful environment.Proficient with Microsoft Office Suite or related software.Education and ExperienceBS/BA degree (or equivalent) in a relevant scientific field required; advanced degree (MS, PhD, MBA OR JD) is preferred.Minimum of 10 years of experience in regulatory affairs, quality, and CMO management with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry.Minimum of 10 years of GMP/QA experience in the pharmaceutical industry.Physical RequirementsProlonged periods of sitting or standing at a desk and working on a computer.Prolonged periods of standing/walking.Must be able to lift up to 15 pounds at times. 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.
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