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 work closely with these groups in meeting company goals. This position will be responsible for ensuring efficient and productive regulatory submissions for BioCryst, 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.

Responsibilities

• 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 oversite 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.

Qualifications

• Bachelor’s degree required (advanced degree MS, PhD, PharmD, MD preferred), preferably in a scientific discipline, with experience in the pharmaceutical industry including at least 10 years in regulatory affairs or an equivalent combination of education and experience.
• Ability to maintain high ethical standards.
• Strong decision-making skills.
• Ability to work as part of a team, both in a leadership role and as a contributing member of the company.
• Ability to develop and maintain positive working relationships with regulatory authorities.
• Strong interpersonal skills and effective written and verbal communication and presentation skills.
• Thorough knowledge of US FDA regulations and guidance regarding product development (IND), NDA/CTD preparation and submission, as well as post-marketing requirements.
• Computer literate (e.g., MS Word, MS PowerPoint, MS Excel).

Education

• Advanced degree (MS, PhD, PharmD, or MD) preferred.