Senior Regulatory Affairs Director - San Francisco, CA, United States - Abdera Therapeutics

Description

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.

The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells.

Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options.

Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy

We are building an exciting and fast paced company passionate about discovering and developing tomorrow's most innovative cancer therapies.

Develop and implements regulatory strategies and contingencies for assigned programs, in order to support Abdera's development objectives.
Participate in global project team meetings provide regulatory support and guidance and manage day-to-day regulatory activities.

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

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

Edit or lead the editing of scientific sections of regulatory documentation against the 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 products/devices development, acquisition or in-licensing of new product or devices.

Maintain knowledge of regulatory environment, global regulations and guidance
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures
Support in the preparation of the Regulatory Affairs department budget
Bachelor's degree in chemistry, biochemistry, pharmacy, pharmacology, or related scientific discipline required.
~ Master's Degree, PharmD or PhD preferred.
~10+ years of relevant experience in a similar role within the biotechnology or pharmaceutical industry
~7 + years in regulatory affairs
~ Ability to interpret and understand US regulations governing pharmaceutical industry.
~ Ability to critically review regulatory scientific documents across non-clinical and clinical disciplines.

Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes in order to create the most efficient and effective methods to deliver quality clinical trial services.

Willingness to collaborate with team to identify and implement in best practices for optimizing performance.

Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.

Demonstrated ability to manage and coordinate internal and external resources independent from managerial oversight.
Ability to prioritize, delegate and execute to meet project deadlines.
Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms).
At ease in start-up environment and effectiveness to deliver in low-structured environments.
Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace.

At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.