Director, Global Regulatory CMC

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable 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 www.biocryst.com or follow uson LinkedInand Instagram.

JOB SUMMARY:

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Manages all global regulatory activities, providing leadership and consultation for global regulatory CMC activities from early development through approval.
• Develops regulatory CMC strategy and prepares CMC submissions to the FDA, EMA, PMDA, Health Canada and other health authorities.
• Works closely with Clinical, Non-clinical, Chemical Development, Pharmaceutical Development, and Quality Assurance, and responsible for managing and preparing CMC regulatory submission documents for assigned projects including INDs, CTAs, IMPDs and BLAs/ NDA s, MAAs and JNDAs.
• Provides strategic regulatory input for manufacturing site transfers.
• Determines submission contents for product changes from manufacturing facilities.
• Reviews and provides approval for specifications, stability protocols, product change notices and related documents.
• Provides day-to-day regulatory advice to product development and quality assurance functions.
• Manages regulatory CMC timelines, ensuring regulatory strategies are executed within approved timelines and advises the program leads and senior leadership of any risks to timelines or potential regulatory problems.
• Develops and maintains excellent working relationships with internal and cross-company project teams and serves as primary CMC liaison to these teams to advocate the company's regulatory CMC position.
• Maintain currency with FDA regulations and guidance, including those pertaining to INDs, and BLAs/NDAs. Is familiar with analogous Ex-US (e.g. EMA, PMDA, etc) regulations and guidance.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• A bachelor's degree in a scientific discipline is required with an advanced degree (MS, PhD) desired.
• Minimum of 10 years' regulatory CMC experience or an equivalent combination of education and experience.
• Experience authoring the CMC portions of IND and BLA filings, as well as experience with drug/device combination products.
• Experience participating in regulatory agency meetings, including preparation of CMC related portions of meeting requests and briefing documents.
• Ability to develop and maintain positive working relationships with regulatory authorities as appropriate.
• The individual must be able to multi-task projects and quickly adapt to change.
• Must have a working knowledge of FDA, EU and ICH CMC regulations and guidances. International regulatory experience is a plus.
• Knowledge of small and large molecule manufacturing processes, validation processes and analytical methods is required.
• Knowledge of FDA, EMA, ICH and other Health Authority CMC regulations and guidance for investigational products, as well as for preparation and submission of marketing applications.
• Strong leadership and interpersonal skills.
• Must be highly proficient in use and knowledge of the English language, grammar and punctuation with strong written and verbal communication skills in the form of technical writing abilities and/or editorial experience and presentations.
• Computer literate (e.g., MS Word, MS PowerPoint, MS Excel).

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.