Exec. Director, Regulatory Strategy

Durham, United States

BioCryst Pharmaceuticals

Posted on: January 14, 2021

Closing: February 13, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in Japan and the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.

 

JOB SUMMARY:

Responsible for providing leadership, therapeutic area knowledge and strategic guidance in all regulatory aspects for all assigned products/projects. The Executive Director will develop and implement global regulatory strategy for multiple projects in development and ensure compliance with global regulatory requirements. She/he will be accountable for driving strategic messaging and serve as the primary regulatory interface with global regulatory agencies.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provide regulatory strategic input to Product Teams for the US and, in consultation with outside consultants, for the EU, Canada and other regions.
• Develop regulatory strategy(s) for interactions with health authorities to support program objectives.
• May serve as the primary regulatory representative in the Product Teams.
• Work with assigned Product Teams to determine the content of all regulatory dossiers and documents. Review and the final sign-off of regulatory submissions for assigned products/projects.
• Predict health authority questions and objections and addresses them prospectively in the dossier (or manages them promptly) to achieve approval with minimal delays.
• Provide strategic input to target labeling (SmPC, US Package Insert, container packaging, etc.) content. • Provide strategic input to product lifecycle issues.
• Participate in authority meetings as appropriate. May serve as delegation Head.
• Provides regulatory Due Diligence support for merger, acquisition, partnering and licensing activities for assigned products/projects.
• Check conformity of press releases, external communications and advertisements, as appropriate for assigned products/projects.
• Work closely with and coordinate project related activities with Regulatory Manager, Regulatory Operations, Regulatory CMC and Medical Writing to ensure appropriate regulatory support for products/projects.
• Collect and analyze information of regulatory and competitive environment and share with Product Teams and Leadership Team as appropriate.
• Represent Regulatory Affairs on Promotional Review Committee for assigned products.
• Develop relationships with other regulatory professionals, associations and authorities.
• May form and lead the Regulatory sub-team for assigned projects/products.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• MD or Ph.D. degree in a science-related field or an equivalent combination of education and experience required.
• A minimum of 10 years of combined drug development/regulatory experience, including interacting with major Health Authorities, and experience with IND and NDA submissions required.
• Ability to think ‘analytically as well as strategically’ with the ability to convey complex concepts in an understandable manner.
• Ability to understand, manage and lead in a multi-cultural atmosphere.
• Ability to work successfully in a ‘team-based’ environment.
• Proven leadership, project management, development of people, and process improvement abilities.
• Excellent interpersonal communications, organizational, and presentation skills.
• Superior negotiation and influencing skills.
• Fluent command of spoken and written English.
• Ability and willingness to travel nationally and internationally.
• Experience with ex-US Regulatory Submissions, e.g., EU MAA, Canadian NDS.
• Knowledge of therapeutic areas to be assigned.

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.


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

BioCryst Pharmaceuticals

Posted on: January 14, 2021

Closing: February 13, 2021

Salary($): Undisclosed

Position Type: Full Time

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