3 Jobs in Menlo, CA
Summit Therapeutics is Hiring a Senior Manager, Regulatory Affairs Near Menlo, CA
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 RoleReporting 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
- BA/BS degree in the biological or health related sciences required, Master’s, 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 guidance’s, 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
Job Summary
Full Time
$159k-211k (estimate)
06/27/2024
12/22/2024
summitplc.com
Cambridge, MA
25 - 50
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The job skills required for Senior Manager, Regulatory Affairs include Regulatory Affairs, Leadership, Planning, Commitment, Clinical Trial, Drug Development, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Manager, Regulatory Affairs. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Manager, Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
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