Senior/executive Director, Head Of Regulatory Affairs

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.