Director, Regulatory Affairs

At Bio Cryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama.

Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at  or follow us on Linked In and Instagram.

The Director of Regulatory Affairs at Bio Cryst Pharmaceuticals (Bio Cryst) will work closely with product development core teams and sub teams in setting company goals and work closely with these groups in meeting company goals. This position will be responsible for ensuring efficient and productive regulatory submissions for Bio Cryst, as well as assisting and collaborating in strategic drug development program implementation.

The position will work to develop and implement key new values and added initiatives focused on the coordination of the company’s regulatory program and product development missions.

• Support regulatory strategies for assigned projects that will result in the on-time submission and approval of new products, indications, and variations and ensure proper maintenance of existing product applications.
• Support and manage the preparation of all US regulatory submissions on assigned projects, including INDs and NDAs/BLAs.
• Work with Regulatory Operations to compile and submit all US regulatory submissions, including INDs, NDAs, and other required US regulatory filings as necessary.
• Manage regulatory timelines ensuring that regulatory strategies are executed within approved timelines and communicating identified risks to the timelines to senior management.
• Interact with US FDA for the coordination and preparation of meetings and teleconferences and conduct informal interactions with the Agency’s personnel as directed by senior regulatory management.
• Maintain currency with FDA regulations and guidance, including those pertaining to INDs, NDAs, electronic submission requirements, labeling, and review of promotional materials. Is familiar with analogous Ex-US (e.g., EMA, PMDA, etc.) regulations and guidance.
• Provide support to the project teams for submissions to ex-US regulatory authorities, including MAAs, CTAs, PIPs and other filings as necessary.
• Responsible for leading activities associated with the development and maintenance of the Company Core Data Sheet (CCDS) for assigned projects and working with Medical and Safety in the development of the Company Core Safety Information (CCSI).
• Responsible for leading all activities associated with the development, review, approval and submission of Prescribing Information and Patient Labeling including working with appropriate team and leadership staff to ensure that product labeling is consistent with the overall strategy for the product and consistent with the Company Core Data Sheet.
• Provide regulatory review of all promotional and medical affairs materials as a member of the Legal, Medical, and Regulatory (LMR) team.
• Review/revise/draft Standard Operational Procedures as required to assure compliance with FDA Regulations and Guidance Documents.
• Provide mentoring and oversight of direct reports by clearly communicating job expectations and job responsibilities, monitoring and assisting with work progress as needed, and facilitating growth opportunities to maximize potential.
• All other duties as assigned.

• Bachelor’s degree required (advanced degree MS, PhD, Pharm
  
  D, MD preferred), preferably in a scientific discipline, with experience in the pharmaceutical industry including at least 10 years in regulatory affairs…