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

Skills and Abilities

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. :

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.

#J-18808-Ljbffr