Regulatory CMC Contractor

JOB SUMMARY:

This position will be responsible for helping to ensure efficient and productive regulatory submissions and operations for BioCryst and work closely with teams in meeting company goals. The position will work to develop and implement key new values and added initiatives focused on the coordination of the company's regulatory program and product developmental missions. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Work closely with Product Development, Chemical Development, Analytical/QC, and QA and be responsible for the preparation of CMC regulatory submissions including INDs, NDAs, IMPDs, and other regulatory submissions.
• Obtain documentation necessary to support CMC submissions.
• Compile/prepare CMC submissions according to current regulatory guidelines.
• Review submissions material for accuracy, completeness, and compliance with regulatory guidelines, as needed.
• Enhance personal technical skills necessary for CMC submissions, and serve as a technical resource for other CMC team members.
• Manage timelines for regulatory submissions and CMC product-related goals.
• Provide critical review of specifications, analytical methods, stability protocols, and other CMC documents.
• Serve as a resource for regulatory guidance and other documents required to meet CMC team objectives.
• Review new regulatory guidance documents and assess impact on projects.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree in a Scientific discipline is required.
• Pharmaceutical Industry experience preferred or an equivalent combination of education and experience.
• Strong interpersonal skills and ability to work effectively in a team environment.
• Knowledge of US FDA regulations and guidance regarding product development (IND), NDA/CTD preparation and submissions; knowledge of EU and Canadian regulations preferred.
• Knowledge of pharmaceutical manufacturing processes, validation processes, and analytical methods is preferred.
• Excellent written and verbal communication and presentation skills.
• Ability to plan, manage and coordinate multiple projects as assigned and complete in a timely fashion.
• Computer literate (e.g., MS Word, MS Excel, MS PowerPoint).

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.