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BioCryst Pharmaceuticals, Inc. · 1 hour ago

Director, Regulatory Affairs

United States

Full-time

Remote

Director/Executive

10+ years exp

BioCryst Pharmaceuticals is committed to improving the lives of people living with rare diseases. The Director of Regulatory Affairs will work closely with product development teams to ensure efficient regulatory submissions and collaborate on strategic drug development programs.

BiotechnologyClinical TrialsTherapeutics

Responsibilities

Support regulatory strategies for assigned projects that will result in the on-time submission and approval of new products, indications, and variations and ensure proper maintenance of existing product applications

Support and manage the preparation of all US regulatory submissions on assigned projects, including INDs and NDAs/BLAs

Work with Regulatory Operations to compile and submit all US regulatory submissions, including INDs, NDAs, and other required US regulatory filings as necessary

Manage regulatory timelines ensuring that regulatory strategies are executed within approved timelines and communicating identified risks to the timelines to senior management

Interact with US FDA for the coordination and preparation of meetings and teleconferences and conduct informal interactions with the Agency’s personnel as directed by senior regulatory management

Maintain currency with FDA regulations and guidance, including those pertaining to INDs, NDAs, electronic submission requirements, labeling, and review of promotional materials. Is familiar with analogous Ex-US (e.g. EMA, PMDA, etc) regulations and guidance

Provide support to the project teams for submissions to ex-US regulatory authorities, including MAAs, CTAs, PIPs and other filings as necessary

Responsible for leading activities associated with the development and maintenance of the Company Core Data Sheet (CCDS) for assigned projects and working with Medical and Safety in the development of the Company Core Safety Information (CCSI)

Responsible for leading all activities associated with the development, review, approval and submission of Prescribing Information and Patient Labeling including working with appropriate team and leadership staff to ensure that product labeling is consistent with the overall strategy for the product and consistent with the Company Core Data Sheet

Provide regulatory review of all promotional and medical affairs materials as a member of the Legal, Medical, and Regulatory (LMR) team

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

Provide mentoring and oversite of direct reports by clearly communicating job expectations and job responsibilities, monitoring and assisting with work progress as needed, and facilitating growth opportunities to maximize potential

All other duties as assigned

Qualification

Regulatory AffairsFDA RegulationsIND/NDA SubmissionTeam LeadershipComputer LiteracyInterpersonal SkillsCommunication Skills

Required

Bachelor's degree required, preferably in a scientific discipline

experience in the pharmaceutical industry including at least 10 years in regulatory affairs or an equivalent combination of education and experience

Ability to maintain high ethical standards

Strong decision-making skills

Ability to work as part of a team, both in a leadership role and as a contributing member of the company

Ability to develop and maintain positive working relationships with regulatory authorities

Strong interpersonal skills and effective written and verbal communication and presentation skills

Thorough knowledge of US FDA regulations and guidance regarding product development (IND), NDA/CTD preparation and submission, as well as post-marketing requirements

Computer literate (e.g., MS Word, MS PowerPoint, MS Excel)

Preferred

advanced degree MS, PhD, PharmD, MD preferred

Company

BioCryst Pharmaceuticals, Inc.

BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases.

Founded in 1986

Durham, North Carolina, USA

501-1000 employees