Attovia Therapeutics
Creating medicines for immune-mediated disease based on Attobody®, a novel biparatopic nanobody platform.
11 - 50
Senior/Executive Director, Head of Regulatory Affairs
August 27
🏢 In-office - Bay Area
Attovia Therapeutics
Creating medicines for immune-mediated disease based on Attobody®, a novel biparatopic nanobody platform.
11 - 50
Description
• Develop and implement innovative, competitive global regulatory strategies for all pipeline programs. • Provide regulatory leadership to project teams by examining regulatory strategy options, providing relevant regulatory precedents/pathways, and staying abreast of trends in the regulatory landscape. • Identify and assess regulatory risks associated with development programs and define approaches to mitigate risks. • Oversee all regulatory filings and interactions, including authorship of critical documents as needed, with a keen eye towards applying scientific/medical knowledge to create cohesive messages. • Serve as primary interface with FDA and various other relevant health authorities. • Lead operational aspects of preparing all regulatory submissions, including managing timelines, maintaining submission tracking information, and keeping management informed on the status of business-critical submissions. • Partner closely with manufacturing and quality teams providing strategic advice on technical and regulatory CMC topics. • Directly manage any regulatory responsibilities outsourced to CROs. • Review out-licensing and partnership opportunities as needed. • Mentor and develop key talent at Attovia.
Requirements
• At least 10 years of relevant work experience (biopharmaceutical industry, FDA, or academia) with at least 8 years operating in a regulatory capacity. • BS or BA in science/technology or an equivalent combination of certified education and work experience. • Demonstrated successful track record of interacting with regulatory health authorities and effectively moving products through the development process; specifically, experience leading the preparation and submission of IND applications for biologic therapeutics. • Current and strong working knowledge of regulatory requirements including GMP/GCP, eCTD submission standards, and ICH guidelines. • Proven project management skills to support the planning and coordination of regulatory submissions and appropriate regulatory inspections. • Strong writing skills, including fluency with common scientific and medical terminology. • Excellent communication and collaboration skills, including working closely with internal and external team members. • Takes ownership, solution-oriented, highly resourceful, and pro-active (vs. reactive). • Capable of working independently in a fast-paced, team-oriented environment. • Ability and willingness to be hands-on when needed.
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