VP, Global Regulatory Affairs

COMPANY:

At BioCryst, 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, our European headquarters is in Dublin, Ireland 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 www.biocryst.com or follow uson LinkedIn and Instagram.

JOB SUMMARY:

The VP, Global Regulatory Affairs at BioCryst Pharmaceuticals (BioCryst) is an executive position with extensive experience in personnel management, operations, and high level regulatory strategic support in a pharmaceutical setting. This position will work closely with the senior leadership personnel of the company to ensure robust regulatory development strategies are developed and implemented for the pipeline development projects and key lifecycle management projects for marketed products. This position will be responsible for ensuring efficient and productive regulatory strategy, planning and submission writing for BioCryst, as well as assisting and collaborating in strategic drug development program implantation. The position will facilitate development and implementation of key initiatives focused on the regulatory strategy to support the company's clinical programs, as well as the integration of the clinical and regulatory strategic plan into the research, and product developmental missions. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provide leadership and direction for regulatory activities, including input into clinical development plans, protocol design, and assessment of study results to meet regulatory and scientific objectives.
• Oversee and participate in the Company's interactions with Health Authorities.
• Drive the creation and implementation of regulatory strategies.
• Interface with internal research and business development teams, and with external academic and governmental scientists and clinicians.
• Identify and recruit and/or assist in recruiting full-time staff in Regulatory Affairs Strategy, Planning and Submissions Group.
• Identify and manage regulatory consultants, and other related third-party relationships.
• Maintain up-to-date working knowledge of laws, regulations, and guidelines across the European and International regions.
• Work with the appropriate partners within BioCryst to establish, update, and implement relevant regulatory policies, standards, and procedures for the Regulatory Strategy, Planning and Submissions Group.
• Work closely with Global Regulatory Operations on electronic submissions and provide input on format and content of European regulatory submissions.
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree required, preferably in a scientific discipline, with experience in the pharmaceutical industry including a minimum of 15+ years in Global Regulatory Affairs. A Master's degree is highly preferred.
• Strong decision-making skills and proven track record leading the regulatory aspects of development programs
• Integrity, ownership mentality, and a commitment to excellence
• Proven leader managing geographically diverse teams
• Strong interpersonal skills and desire to work with GRLs and project teams
• Results-oriented individuals with a strong work ethic and proven track record of successful CTA, MAA, IND, NDA submissions
• Experience in rare disease highly preferred
• Strong knowledge of the European Centralized Procedure and experience working directly with the USFDA and European Regulatory Authorities; experience working with the PMDA (Japan) Regulatory Authorities is highly desired
• Good knowledge and understanding of the International regulatory environments
• Must be highly proficient in use and knowledge of the English language, grammar and punctuation with strong written communication skills in the form of technical writing abilities and/or editorial experience

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.