Senior Manager, Regulatory Affairs

We’re a Peninsula-based biopharmaceutical company committed to improving the lives of patients in need, and we’re on the cusp of some very significant milestones.

The Senior Manager, Regulatory Affairs will be responsible for assisting with the preparation and execution of global regulatory submissions and strategies with a focus on European Regulatory Agency interactions. This position reports to the Senior Director, Regulatory Affairs.

- Review protocols, reports and other supporting documentation (i.e., quality, safety, efficacy, and labeling) to be included in regulatory submissions (e.g., MAA, NDA, CTA, IND, Scientific Advice, responses to questions from Health Authorities, PIP, PSP, DSUR, etc.) for accuracy and completeness and compliance with applicable regulations and guidance as well as Relypsa SOPs, where appropriate - Participate in MAA submission activities and projects and support other MAA activities, as needed - Assist with managing regulatory agency interactions, document preparation, co-ordination of meeting rehearsals and minutes - Independently manage and contribute to the preparation of Clinical Trial Applications, including developing submission strategies to ensure earliest possible approvals to conduct the studies and directing the CRO in the implementation of these strategies - Independently manage routine regulatory submissions (e.g., Annual Reports, DSURs, Investigator Updates, etc.) - Provide regulatory support to the Clinical, Nonclinical and CMC teams regarding the regulatory requirements for conducting clinical trials and obtaining marketing authorization in Europe - Coordinate with other Regulatory personnel and personnel from other departments, as required, to complete assigned projects - Inform Regulatory personnel and personnel in other departments of new regulatory guidance and regulations

- BS or higher degree in science or law, or equivalent, with at least 5 years of experience in Regulatory Affairs including 1-2 years of experience in international regulatory affairs - Experience in preparation and submission of CTAs and amendments - Experience in preparation and submission of a MAA/NDA is preferred but not required - Strong knowledge of ICH requirements and guidelines and CTA/IND/MAA/NDA/eCTD requirements - Experience with preparation of documentation to support regulatory agency interactions - Manages (initiates, directs and completes) defined projects within agreed-upon parameters and timelines - Shows strong initiative and drive. - Must be an organized self-starter who is able to anticipate departmental needs - Excellent interpersonal and communication skills are essential. - Ability to work successfully within a cross-functional team - Must be able and willing to work in a fast-paced environment while handling multiple priorities. - Must be flexible, detail-oriented, and possess excellent analytical and problem-solving skills - Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat