Director, Regulatory Affairs

BioCryst Pharmaceuticals, Inc.; United States; On-site; USD 130,000 - 180,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Regulatory Affairs to manage regulatory submission strategies and ensure compliance with US FDA regulations. This role requires a Bachelor's degree in a scientific discipline, with preferred advanced degrees and at least 10 years of relevant experience. Key responsibilities include overseeing regulatory submissions for new products and maintaining relationships with regulatory authorities. Strong interpersonal and communication skills are essential for success in this position.

Qualifications

• Bachelor's degree required with 10+ years of experience in regulatory affairs.
• Ability to maintain high ethical standards.
• Thorough knowledge of US FDA regulations.

Responsibilities

• Support regulatory strategies for on-time submission and approval of products.
• Manage US regulatory submissions, including INDs, NDAs, and other filings.
• Lead activities associated with the development of Company Core Data Sheet.

Skills

Regulatory affairs expertise

Strong decision-making skills

Interpersonal skills

Effective communication

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PhD, PharmD, MD)

Tools

MS Word

MS PowerPoint

MS Excel

Job description

Join to apply for the Director, Regulatory Affairs role at BioCryst Pharmaceuticals, Inc.

Company Overview

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in‑class or best-in‑class oral small‑molecule and protein therapeutics, led by 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.

Job Summary

The Director of Regulatory Affairs at BioCryst Pharmaceuticals (BioCryst) will work closely with product development core teams and sub‑teams in setting company goals and in meeting those goals. The position will be responsible for ensuring efficient and productive regulatory submissions for BioCryst, as well as assisting and collaborating in strategic drug development program implementation. The role will develop and implement key initiatives focused on the coordination of the company’s regulatory program and product development missions.

Essential Duties & Responsibilities

• Support regulatory strategies for assigned projects resulting 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 communicate identified risks to senior management.
• Interact with US FDA for 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. 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.
• Lead activities associated with the development and maintenance of the Company Core Data Sheet (CCDS) for assigned projects and work with Medical and Safety in the development of the Company Core Safety Information (CCSI).
• Lead all activities associated with the development, review, approval and submission of Prescribing Information and Patient Labeling, ensuring product labeling is consistent with overall strategy and 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, and draft Standard Operational Procedures to assure compliance with FDA regulations and guidance documents.
• Provide mentoring and oversight of direct reports, clearly communicating job expectations and responsibilities, monitoring work progress, and facilitating growth opportunities.
• All other duties as assigned.

Experience & Qualifications

• Bachelor’s degree required (advanced degree MS, PhD, PharmD, MD preferred), preferably in a scientific discipline, with 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).

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.