Senior Manager, Regulatory Affairs

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
• 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 preferred
• Minimum of 3 years of experience in regulatory affairs
• Minimum of 5 years of pharmaceutical, biotechnology, or life sciences 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

The pay range for this role is $153,000-$180,000 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.

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