Sr. Manager, Regulatory Affairs

COMPANY:

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 the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram. 

 

JOB SUMMARY:

The Sr. Regulatory Affairs Manager Europe & Rest of the World (EUROW) will work closely with the Exec. Director Regulatory Affairs Europe & ROW, internal stakeholders from HQ-based functions, business stakeholders and external stakeholders, as well as product development teams and sub teams in setting company goals and work closely with all these groups in meeting company goals. This position will be responsible for ensuring efficient and productive regulatory submissions for the European and ROW territory. This individual will provide support for the preparation of ROW, EU, UK/I and Switzerland regulatory submissions including but not limited to CTAs and MAAs as well as other pre- a/o post-authorization interactions with regional and local regulators (e.g., scientific advice meetings), as far as applicable. This individual will have the ability to work as part of a team, both in a leadership role and as a contributing member of the company; and the ability to develop and maintain positive working relationships with regulatory authorities. He/she will possess strong interpersonal skills and the ability to work collaboratively and will be an effective communicator with excellent written and verbal communication and presentation skills.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Support and inform 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.
• Working with Regulatory Operations, compile, prepare and submit meeting requests and packages, CTA, MAA, and other required ROW, EU,UK/I and Switzerland (as assigned) regulatory filings as necessary to implement the agreed upon strategy.
• Provide support to Project Teams for submissions to ex-US regulatory authorities.
• Interact with distribution partners in ROW Territories for the coordination and preparation of meetings and teleconferences and conduct informal interactions with the Agency’s personnel as directed by senior regulatory management.
• Review/revise/draft Standard Operational Procedures as required to assure compliance with Regulations and Guidance Documents of Health Authorities in the respective Territory and in line with the company’s global and regional processes and procedures.
• Manage regulatory timelines ensuring that regulatory strategies are executed within those approved timelines. Communicate and manage risks around timelines during the project.
• Maintains currency with relevant regulations and guidance regarding CTAs, MAAs and electronic submission requirements. Is familiar with ROW and EU regulations and guidance and others as appropriate.
• Provide Regulatory Intelligence support to the Project Teams, to include the monitoring, gathering and analyzing of publicly available and experience based regulatory information to support optimization of BioCryst’s drug development programs.
• Keep senior regulatory management advised on project related issues and timelines.
• Develop and maintain strategic relationship with relevant BioCryst and partner business partners to ensure optimal collaborative set up in the pre- and post-authorization space in ROW, EU, UK/I and Switzerland, as assigned.
• Other duties as assigned.
• Provide support to Project Teams for submissions to ex-US regulatory authorities.
• Provide mentoring to junior associates to enable them to function efficiently and effectively.

 

EXPERIENCE & QUALIFICATIONS:

• Bachelor or