Associate Director, Regulatory Affairs Strategy

BioCryst Pharmaceuticals, Inc.

. Work closely with product development core teams and subteams to set and achieve company goals .

Posted 9/28/2026full-timeRemote • North Carolina • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory strategy and submissions within the biotech and pharmaceutical industry, with a strong focus on FDA regulations and global approval processes. Proven ability to lead cross-functional teams and manage regulatory timelines while maintaining high ethical standards.

Highest-signal resume keywords

Regulatory Strategy ExperienceIND/BLA/NDA SubmissionsFDA Regulations KnowledgeCross-Functional Team LeadershipExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory Strategy DevelopmentLifecycle ManagementRegulatory ComplianceIND/CTA KnowledgeBLA/NDA/MAA KnowledgeGlobal Regulatory ExperienceRegulatory Timeline ManagementHealth Authority Meeting PreparationStandard Operational Procedures Drafting

Soft Skills

Organizational SkillsAttention to DetailInterpersonal SkillsTeam CollaborationPositive Relationship Development

Tools & Technologies

MS WordMS PowerPointMS Excel

Industry Keywords

Biotech IndustryPharmaceutical IndustryRegulatory Program CoordinationProduct Development InitiativesPost-Approval Activities

About the role

Key responsibilities & impact

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

What you’ll need

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