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Job Title: Senior Associate, Regulatory Affairs 

Department: Regulatory Affairs

Location: Menlo Park, US

Overview of Role:

Reporting to Senior Director, Regulatory Affairs, the Senior Associate of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects with global regulatory leads. 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 assistance of molecule and study-level regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated regulatory health authority submissions, and manage other regulatory aspects of the studies as necessary
  • Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures
  • Prepare and manage life-cycle/routine submissions and related activities
  • 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 the Project Team representatives in the 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 track record of regulatory/ethics submissions and approvals across all studies
  • Manage document archive processes
  • Support global regulatory submissions and strategic planning as applicable
  • All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

  • BA/BS degree in the biological or health related sciences required; Master’s, PhD or PharmD is preferred
  • A minimum of 3+ years of industry experience, experience in regulatory affairs in oncology preferred
  • Familiarity with US FDA guidances and ICH guidelines, drug development process
  • Knowledge of Chinese is desirable
  • Keen attention to detail; ability to organize, prioritize assigned projects
  • Exposure in interacting with CROs in the management of ex-US CTAs with regard clinical trial activation and/or management of day-to-day activities.
  • Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.
  • Attention to detail, accuracy and confidentiality
  • Clear and concise oral and written communication skills, and ability to communicate effectively
  • Work in a dynamic environment, collaboratively and independently

The pay range for this role is $95,000-$110,000 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.

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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

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