Senior Manager, Regulatory Affairs

Our Mission:

To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, and successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy* intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate.

We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders.

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol SMMT). We are headquartered in Menlo Park, California, and we have additional offices in Oxford, UK & Cambridge, UK.

Overview of Role:

Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Role and Responsibilities:

• Provide ownership of molecule and study-level regulatory activities, including global clinical trial applications (CTAs) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the studies as necessary

• Contribute and drive the regulatory content and strategy for BLA, NDA or marketing authorization submissions

• Provide regulatory guidance internally on study-team decisions

• Update study team of regulatory activities in the context of study team management meetings

• Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions/commitments

• Collaborate with cross-functional study team for planning of regulatory documents, including Health Authority Meetings and responses to Health Authority queries

• Support processes by which regulatory submissions are reviewed, finalized, and signed-off

• Manage the record of regulatory/ethics submissions and approvals across all studies

• Manage document archive processes

• Support global regulatory submissions and strategic planning as applicable

Experience, Education and Specialized Knowledge and Skills:

• BA/BS degree in the biological or health related sciences required, Masters, PhD or PharmD preferred

• Relevant (bio) pharmaceutical industry experience, including experience in regulatory affairs

• Require at least five years of industry experience

• Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices

• Possess strong written, oral communications

• Demonstrate proven interpersonal skills and experience working cross-functionally throughout the organization

• Detail-oriented, ability to work proactively, organize, prioritize, and delegate assigned projects

• Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred as well as ex-US health authority interactions, meetings etc.

• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

• Knowledge of Chinese is desirable

The pay range for this role is $169,000 to $195,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits human resources department to obtain prior written authorization before referring any candidates to Summit.