The Senior/Executive Director of Regulatory Affairs will be an essential part of the development team and will report to the Chief Medical Officer. The position will be responsible for defining the regulatory strategy and leading all company interactions with the FDA, or country-specific health authorities, for Attobody-based therapeutics. The Senior/Executive Director of Regulatory Affairs will be accountable for ensuring that all regulatory deliverables are of the highest quality and that all regulatory submission requirements are met. Additional responsibility includes representing regulatory as a member of cross-functional program teams that define, implement, and execute the global development strategies for Attovia's pipeline programs. This is an on-site position.
Key Responsibilities
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
Basic Qualifications
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
Preferred Qualifications
Strong knowledge with first-in-human and early proof-of-concept studies
Experience leading Type B meetings (pre-IND or end-of-Phase 1) with FDA
Experience working with novel biologic formats, such as bispecific/multi-specifics, nanobodies, and/or extended-format modalities.
Experience with development programs in dermatology or prior interactions with the dermatology division at the FDA
Experience reviewing CMC content in regulatory applications to ensure that it is complete, well-written, and meets all relevant requirements for the program’s development phase
Experience interacting with health authorities in Canada, Australia/New Zealand, or EU
Experience working at start-up company with less than 100 employees
Demonstrated ability to manage direct reports
Experience working with Compliance and Quality Assurance to define and develop fit-for-purpose SOPs for regulatory activities
Advanced degree (MS/MA or PhD) in a related scientific/medical field
About Attovia
Attovia is creating a pipeline of biotherapeutics with initial focus immune-mediated disease. The company leverages Attobody™, a novel biologics platform, to generate small format biparatopic binders that expand the addressable target universe across disease areas and can offer stronger efficacy, faster speed to response, and an improved safety profile than traditional approaches. We are currently progressing multiple programs across immune-mediated disease indications.
Our culture is centered around five core pillars:
Integrity
Learning & Growth
Drive for Excellence
Innovation
Teamwork & Collaboration
We take pride in fostering a strong team and dynamic work environment, and we are seeking individuals who align with our values and contribute to a positive and impactful workplace.
Attovia is located in Fremont, CA, with planned future relocation to the mid-Peninsula area in 2025.
Attovia is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Learn more about Attovia: www.attovia.com
Leveling and salary is commensurate with experience.
Senior Director: $250,000-$280,000
Executive Director: $280,000-$305,000
Seniority level
Not Applicable
Employment type
Full-time
Job function
Legal
Industries
Biotechnology Research
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