Assoc. Director, Regulatory Affairs Strategy

ESSENTIAL DUTIES & RESPONSIBILITIES:

• With Director of Regulatory Affairs oversight, this position will manage initial global approvals and global post-approval activities for advanced programs working with partnering companies

• Manage and support post-approval maintenance activities for marketed products, including lifecycle management submissions in the US and internationally and support development and early-phase regulatory projects as assigned.

• Support regulatory strategies for assigned projects via researching regulations and guidelines ensuring alignment with regional requirements that will result in the on-time submission and approval of new products.

• Working with Regulatory Operations, compile, prepare and submit IND, BLA/NDA and additional US regulatory filings as necessary to implement the agreed upon strategy.

• May serve as the Global Regulatory Lead (GRL) for defined projects and deliverables that may include, and not limited to, leading identified workstreams; attend clinical study team meetings; track and keep reg subteams and program teams current with status of regulatory submissions and any changes in strategies.

• May support GRL for additional programs on defined workstreams and deliverables including in the coordination and preparation of Health Authority meetings.

• Review/revise/draft Standard Operational Procedures as required to assure compliance with Global Regulations and Guidance Documents.

• Manage regulatory timelines and manage/communicate timeline and/or content risks to Director of Regulatory Affairs Strategist or GRL ensuring that regulatory strategies are executed within those approved timelines.

• Maintains current with FDA regulations and guidance regarding INDs, BLAs/NDAs, while developing familiarity with global regulations.

• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree required with advanced degree (MS; PhD, PharmD) a plus

• Eight (8) to ten years regulatory strategy experience in the biotech/pharmaceutical industry.

• Ability to maintain high ethical standards.

• Excellent organizational skills, attention to details, and communication skills.

• Ability to work as part of a team, both in a leadership role on assigned duties and as a contributing member of the company.

• Ability to develop and maintain positive working relationships across cross-functional teams.

• Strong interpersonal skills with demonstrated ability to serve as a strong, collaborative partner with internal and external stakeholders and effective written and verbal communication and presentation skills.

• Thorough knowledge of US FDA regulations, with Global experience a plus, regarding product development (IND/CTA), BLA/NDA/MAA with a sense of curiosity driving continuous learning and program success.

• Effective written and verbal communication, presentation skills and 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

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