Director_Sr. Director, Regulatory Affairs

Who we are

Abdera Therapeutics Inc. is a precision oncology company developing next‑generation targeted radiation therapies—one of the most cutting‑edge and highly promising areas of drug development. We have built a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy tissue. Using this platform we are rapidly advancing a broad range of safe and efficacious therapies for cancer patients with limited treatment options.

What we look for

We seek curious, committed individuals ready to transform how people living with cancer are treated. We value collaboration, respectful engagement, and inclusive problem‑solving in a fast‑paced, innovation‑driven environment. Ideal candidates bring scientific rigor and emotional intelligence to deliver hope through breakthrough therapies.

Salary range : $200‑270K

Hybrid schedule with 3 days per week in our SSF office; remote options for candidates with a radiopharmaceutical background.

Principal Responsibilities

Develop and implement regulatory strategies and contingencies for assigned programs to support Abdera’s development objectives.

Lead and prepare FDA submissions.

Participate in global project team meetings, providing regulatory support and guidance and managing day‑to‑day regulatory activities.

Provide guidance and expertise to senior management and other departments on all regulatory issues for strategic development, planning, compilation, and submission of all regulatory filings.

Serve as the primary contact with FDA, liaising, negotiating, and orchestrating all interactions.

Provide mentorship to multidisciplinary teams on content, format, style, and architecture of an Investigational New Drug (IND) application.

Edit or lead the editing of scientific sections of regulatory documentation to meet regulatory requirements; assist with the writing, review, and preparation of an IND application.

Manage the organization, preparation, and review of IND amendments, annual reports, and other regulatory documents and correspondence.

Participate in due diligence activities and communicate regulatory risks before product / devices development, acquisition, or in‑licensing.

Provide support on labeling and advertising matters.

Maintain knowledge of regulatory environment, global regulations, and guidance.

Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.

Support preparation of the Regulatory Affairs department budget.

Qualifications, Education & Experience

Bachelor’s degree in chemistry, biochemistry, pharmacy, pharmacology, or related scientific discipline required.

Master’s Degree, PharmD, or PhD preferred.

7‑10+ years of relevant experience in a similar role within biotech or pharma.

5‑7+ years in regulatory affairs.

Radio expertise is a plus.

Ability to interpret and understand US regulations governing the pharmaceutical industry.

Comprehensive understanding of drug development concepts, including clinical trial design, statistics, and clinical pharmacology.

Strong written, verbal, and interpersonal communication skills; able to interact with individuals at all levels.

Prior experience with FDA submissions required.

Skills and Abilities

Critically review regulatory scientific documents across non‑clinical and clinical disciplines.

Build a learning environment that values each contributor and promotes a solutions orientation.

Constructively challenge, question, and provide creative suggestions for regulatory trial processes to improve efficiency and quality.

Collaborate with the team to identify and implement best practices for optimizing performance.

Demonstrate emotional intelligence and clear, persuasive communication; build strong relationships.

Lead team members and vendors with strong leadership skills.

Manage and coordinate internal and external resources independently.

Prioritize, delegate, and execute to meet project deadlines.

Proactive, innovative, with excellent problem‑solving skills.

Advanced computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, IXRS / EDC platforms).

Comfortable in a startup environment, delivering in low‑structured settings.

At Abdera, we recognize the importance of attracting and retaining the best talent and are committed to offering competitive compensation and comprehensive benefits tailored to your needs.

Here’s what you can expect when you join our team in the U.S. :

Competitive Base Pay : Expected base pay range $200‑275k (USD), plus performance‑based bonuses.

Comprehensive Benefits : Health, Dental, Vision, Prescription drug coverage; Basic Life and AD&D insurance; Long‑Term and Short‑Term disability; 16 paid company holidays; 20 days PTO and 6 sick days; 401(k) plan with up to 3.5% company match, equity and bonus.

Personalized Pay : Individual pay determined by job‑related skills, experience, and relevant education or training to ensure fair and competitive compensation.

Work‑Life Balance : Hybrid work schedule with 3 days on‑site, along with development and growth opportunities.

We value our employees and strive to create an environment where you can thrive professionally and personally.

Abdera is an equal‑opportunity employer committed to diversity and inclusion. We prohibit harassment and discrimination of any kind based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or other protected characteristics under applicable laws. This applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

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