Director, Regulatory Affairs

Role Summary

The Director of Regulatory Affairs at BioCryst Pharmaceuticals will work closely with product development core teams and sub teams in setting company goals and working with these groups to meet those goals. This position is responsible for ensuring efficient and productive regulatory submissions and will assist in strategic drug development program implementation, developing and implementing initiatives focused on coordinating the company’s regulatory program and product development missions.

Responsibilities

• Support regulatory strategies for assigned projects to enable on-time submission and approval of new products, indications, and variations; maintain existing product applications.
• Prepare and manage all US regulatory submissions on assigned projects, including INDs and NDAs/BLAs.
• Collaborate with Regulatory Operations to compile and submit US regulatory filings as necessary.
• Manage regulatory timelines and communicate risks to senior management.
• Interact with the US FDA for meetings and teleconferences; conduct informal interactions as directed by senior regulatory management.
• Maintain currency with FDA regulations and guidance (INDs, NDAs, electronic submissions, labeling); familiar with analogous Ex-US regulations (e.g., EMA, PMDA).
• Support submissions to ex-US regulatory authorities (MAAs, CTAs, PIPs, etc.).
• Lead development and maintenance of the Company Core Data Sheet (CCDS) and collaborate on the Company Core Safety Information (CCSI).
• Lead activities related to Prescribing Information and Patient Labeling to ensure consistency with strategy and CCDS.
• Provide regulatory review of promotional and medical affairs materials as part of the Legal, Medical, and Regulatory (LMR) team.
• Review/revise/draft Standard Operating Procedures to ensure compliance with FDA regulations and guidance.
• Provide mentoring and oversight of direct reports, including setting expectations and facilitating growth opportunities.
• All other duties as assigned.

Qualifications

• Required: Bachelor's degree in a scientific discipline; at least 10 years of pharmaceutical regulatory affairs experience.
• Preferred: Advanced degree (MS, PhD, PharmD, or MD).
• Required: Ability to maintain high ethical standards; strong decision-making skills.
• Required: Ability to work as part of a team in both leadership and contributing roles; ability to develop and maintain positive relationships with regulatory authorities.
• Required: Strong interpersonal, written, and verbal communication and presentation skills.
• Required: Thorough knowledge of US FDA regulations and guidance for product development (IND), NDA/CTD preparation and submission, and post-marketing requirements.
• Required: Computer literacy (e.g., MS Word, MS PowerPoint, MS Excel).

Education

• Bachelor‚Äôs degree required; advanced degree preferred.

Skills

• Regulatory strategy, IND/NDA/CTD submissions, and global regulatory submissions (ex-US)
• Regulatory operations coordination, project and timeline management
• FDA interactions and regulatory agency communications
• Review of promotional and medical materials; labeling and labeling alignment with CCDS
• Leadership, mentoring, and team development
• Strong written and verbal communication, negotiation, and presentation skills
• Regulatory knowledge across US and international frameworks (EMA, PMDA, etc.)