Vice President, Regulatory Affairs
Our client is a late-stage clinical pharmaceutical company. They have asked us to assist them in a search for a Vice President, Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Plans content, timelines, and coordination of regulatory submissions.
- Drives the creation and refinement of effective and efficient processes to ensure consistency in submissions.
- Identifies regulatory issues and provides solutions to keep programs on time, while maintaining the highest quality standards.
- Leads efforts for coordinating content and publishing documents for INDs, NDAs, and their associated maintenance.
- Oversees efforts to produce regulatory documents including investigator brochures, annual reports, and background documents for regulatory authority meetings.
- Maintains knowledge of the current regulatory environment, contributes to the preparation of new regulatory guidance, comments on draft guidance, and communicates changes in regulatory information to teams and senior management.
- Prepares cross-functional teams for regulatory interactions as well as directs, develops, and delivers internal education and training activities.
- Assures compliance with regulatory standards and guidance documents.
- Prepares, submits, tracks, indexes, and archives electronic submissions.
- Serves as a subject matter expert and provides regulatory guidance on development and research teams.
- Understands trends in regulatory affairs and takes a leadership role in assessing and communicating the impact of these requirements.
- Supervises external CRO medical writing and regulatory operations functions for coordinating and publishing submission documents.
- Develops and oversees the budget for the regulatory affairs function.
- A Bachelor’s degree in life sciences or related scientific discipline is required, a Master’s degree is preferred.
- Must have 8+ years of pharmaceutical or biotech industry experience in regulatory affairs, experience in neurodegenerative disease research is highly desirable.
- Requires significant experience in supporting development stage programs (Phase I-IV).
- Knowledge and experience with all phases of clinical studies is required
- Must have proven experience with FDA submissions, IND to NDA, ideally to the neurology and psychiatry divisions.
- Demonstrated experience in interacting with regulatory authorities and preparing cross-functional teams to engage with authorities on an ongoing basis during the development stages is required.
- Must have strong prioritization and problem-solving skills with the ability to juggle multiple high priority projects and to be flexible as new challenges arise.
- Strong facilitation, organization, analytical, and project management skills are required.
- Must be comfortable working in a fast-paced and evolving company environment.
- Requires experience leading, managing, coaching, and developing direct reports.
- Advanced skills with MS Office and Clinical Trial Management Systems is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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