Director, Regulatory Affairs – Bristol, PA
The Director, Regulatory Affairs will provide strategic leadership, oversight, guidance, and operational direction for the Regulatory Affairs team. The Director will ensure the performance of the team supports Virtus’ data integrity standards, compliance with all local and regional regulatory requirements and oversees the development, implementation, communication, and consistent application of relevant regulations, regulatory guidance and precedents. Effective communication with external agencies and a reputation for integrity and ethical behavior is critical. This position requires a hands-on operating style, with attention to details, budgets, and timelines.
- Responsible for the selection, training, development, and performance management for the Regulatory Affairs team.
- Direct and manage Virtus’ interaction with FDA and other health authorities.
- Direct and manage the preparation, submission, and maintenance of ANDAs and other regulatory applications.
- Become an integral part of the portfolio and pipeline development team by providing strategy, recommendations and advice for all filings/applications.
- Responsible for obtaining and maintaining all required state licenses.
- 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.
- Ensure metrics are tracked to demonstrate compliance with Regulatory reporting timelines and guidelines.
- Maintain inspection readiness and assist with preparations in the event of regulatory inspections, as required.
- 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.
ESSENTIAL JOB REQUIREMENTS AND QUALIFICATIONS:
- Excellent written and verbal communication skills.
- Proficient in the delivery and conduct of Regulatory Affairs activities including but not limited to submissions, publishing, review, and oversight.
- Ability to work well under pressure and adhere to deadlines.
- Ability to manage and grow team.
- Detail oriented.
- Established working relationships with regulatory agencies.
- Demonstrated career of high performance in a small company environment is highly desired.
- Proficient in eCTD software.
- Proficient in Excel, Word, and PowerPoint.
EDUCATION AND EXPERIENCE:
- Bachelor’s Degree in Life Sciences or related discipline.
- Minimum of 7 years’ experience in Regulatory Affairs management with a minimum of 5 years’ experience managing Regulatory Affairs staff.
- In-depth knowledge of pharmaceutical Regulatory standards and regulations.