Associate Director, Regulatory Affairs Strategy

🕒 September 28

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• Work closely with product development core teams and subteams to set and achieve company goals • Develop and ensure efficient and productive regulatory strategies and submissions • Assist and collaborate in strategic drug development program implementation • Coordinate the company’s regulatory program and product development initiatives • Manage initial global approvals and global post-approval activities for advanced programs with partnering companies • Manage and support post-approval maintenance activities and lifecycle management submissions in the US and internationally • Support development and early-phase regulatory projects • Research regulations and guidelines to support regulatory strategies and regional requirements • Compile, prepare, and submit IND, BLA/NDA, and additional US regulatory filings • Serve as Global Regulatory Lead for defined projects and deliverables, including leading workstreams and attending clinical study team meetings • Track regulatory submissions and changes in regulatory strategies • Support coordination and preparation of Health Authority meetings • Review, revise, and draft Standard Operational Procedures • Manage regulatory timelines and communicate timeline or content risks • Maintain current knowledge of FDA regulations and guidance regarding INDs and BLAs/NDAs • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree required; 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 • Effective written and verbal communication and presentation skills • Thorough knowledge of US FDA regulations regarding product development (IND/CTA), BLA/NDA/MAA; global experience a plus • Computer literacy, including MS Word, MS PowerPoint, and MS Excel

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