We are a privately held, well-funded, clinical-stage Biotechnology company with a revolutionary technology in producing and delivering biologics in humans. Pioneering innovation in the biologics space, we are developing a diverse platform for various therapeutics including proteins, antibodies, peptides, cytokines, and vaccine allergens, targeting disease indications ranging from infectious to metabolic diseases. The company boasts of innovative leadership, strong academic and industry partnerships and a collaborative culture.

We are currently seeking an experienced Head of Regulatory Affairs who will play a leading role in assembling regulatory submissions to the FDA and overseas governmental agencies. Currently, we have open INDs with the FDA and a few active clinical trials in the U.S. and Australia with several additional clinical trials in planning.

Reporting into the CEO this position requires comprehensive knowledge of FDA regulations and a strategic mindset capable of leading the company through its first BLA submission and beyond.

Role and Responsibilities:

The major tasks for this position during the first six months are as follows:

Interactions with Regulators : Serve as the primary contact for FDA and other regulatory authorities. Prepare teams and coordinate for regulatory meetings (pre-IND, end-of-phase, pre-BLA, etc.).

Regulatory Submissions : Lead preparation, review, and submission of regulatory documents, including INDs, BLAs, NDAs, annual reports, meeting requests, and other regulatory filings with the FDA and other regulators. These submissions require working closely with the CEO and heads of clinical, R&D, quality, and GMP manufacturing as appropriate.

Regulatory Intelligence : Monitor and analyze regulatory landscape, industry trends, and competitor activities. Provide strategic insights and recommendations to the leadership team regarding regulatory implications for product development and commercialization. The novelty of our products and GMP biomanufacturing process create many opportunities to think creatively about improving conventional biopharmaceutical development, including the regulatory process.

Once up to speed on the technology platform and regulatory history:

Regulatory Strategy : With the CEO and heads of clinical, R&D, quality, and GMP manufacturing, further develop our regulatory strategy for the pipeline, including new drug programs and additional regulatory jurisdictions (may include the E.U., Japan, China, and WHO).

Leadership and Supervision : Build and lead the regulatory affairs team as the size and complexity of our clinical portfolio grows.

SOP Development and Implementation : Begin to develop automated tools and standard operating procedures (SOPs) for recurring regulatory affairs activities, with an eye toward improving both efficiency and execution precision.

Depending on prior experience and interests, the following may or may not also be relevant to the role over the long term:

GMP & GCP : We directly operate GMP manufacturing facilities. Initially the quality assurance and quality control functions and clinical data quality will remain in their existing reporting structures, but this may evolve.

Education and Experience:

• Bachelor’s degree.
• Advanced degree in a scientific, healthcare, or related field preferred. Lawyers with experience in FDA law are encouraged to apply.
• Minimum of 10 years of experience in regulatory affairs in biopharmaceuticals or regulatory organizations like the FDA.
• Deep knowledge of:

-drug regulations (FDA, ICH, etc.); familiarity with GMP, GCP, and GLP; and

-regulatory filings, including INDs, BLAs, NDAs, and post-approval activities.

• Experience managing the process of drafting and submitting regulatory submissions, including FDA.
• Project lead experience preferred.
• Experience with the Australian regulatory process is helpful but not strictly necessary.
• Proven ability to develop and execute regulatory strategies, navigating complex regulatory landscapes and achieving successful regulatory outcomes.

Attributes:

• Strong leadership skills, fostering a collaborative and high-performing team environment.
• Strong writing and editing skills; particularly helping others learn to write in “FDA regulatory style,” including some for whom English is not the first language.
• Strong negotiation skills in interactions with regulatory authorities and internal stakeholders.
• Impatience for the slow pace and extreme cost of conventional biopharmaceutical development; a distaste for mindless proceduralism for its own sake.
• A willingness to “roll up the sleeves” and dive into the work deeply; comfort with operating in a lean staffing environment.
• Deep understanding of the fundamental basis of FDA and other regulatory systems, and the ability to use this not just to copy regulatory precedents, but instead develop regulatory strategies from first principles, highly tailored to each product’s unique biological and clinical attributes.
• Detail-oriented personality.
• Continuous learner; passion for staying up with evolving regulatory requirements and best practices.