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VP, Regulatory Affairs
Durham, NC 27713 United States
Competitive Salary, bonus, and generous benefit package
We are currently seeking a Vice President, Regulatory Affairs who will be responsible for regulatory strategy, oversight, and guidance to the Chimerix drug development program. The successful candidate will bring a history of effectively leading cross functional drug development teams and interacting effectively with the FDA and other foreign regulatory bodies. Effective communication with external agencies and a reputation for integrity and ethical behavior is critical. A managerial style of accessibility, coaching, and setting high standards of performance for the staff is important. Although the ability to think strategically is important, this position requires a hands-on operating style, with attention to details, budgets, and timelines.
Reporting directly to the CMO, the principal responsibilities include:
- Direct and manage Chimerix interactions with FDA and other health authorities
- Direct and manage the preparation, submission, and maintenance of INDs, NDAs, and other regulatory applications.
- Assist in Clinical Studies required for Regulatory Approvals, including clinical study design, data analysis, and data reduction
- Inform leadership team of regulatory status of products and significant regulatory issues
- Provide counsel, training, and interpretation of FDA and other regulatory issues to Company personnel and assist as a liaison between the Company and regulatory authorities
- Review and critique documents that will be included in regulatory applications.
- Obtain and disseminate information regarding current activities, trends, and changes in the regulatory environment.
- Host FDA/third party regulatory audits and ensure follow up on findings/observations issued including CAPAs as needed
- M.S. or PharmD/PhD preferred.
- At least 20 years (BS/BA or MS/MA) or 15 years (PharmD or PhD) of experience in the pharmaceutical industry including at least 10 years of relevant experience within Regulatory Affairs.
- Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review, and oversight.
- Thorough understanding of regulations of ICH, FDA, and EMA.
- Knowledge of GLP, GMP, and GCP regulations.
- Ability to work well under pressure and adhere to deadlines.
- Proven ability to manage and grow team.
- Excellent written and verbal communication skills.
- Detail oriented.
- Willing to travel up to 40% both domestic and international.
- A proven track record of successful drug development coupled with positive working relationships with regulatory agencies is required.
- Experience in a global company, with understanding of international regulatory environments is a plus.
- A demonstrated career of high performance in a small company environment is highly desired.
North Carolina Biotechnology Center