Director, Regulatory Affairs
Reports to: Chief Regulatory & Quality Officer
Location: Princeton, NJ
About PMV Pharmaceuticals
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting the reactivation of p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.
This strategic role is responsible for liaising, negotiating, and partnering with the FDA and other global Health Authorities to progress the development of PMV products in the most efficient and compliant manner. In addition, collaborate with team members cross-functionally to ensure submissions are completed with high quality in accordance with timelines.
- Liaise, negotiate and orchestrate meetings and teleconferences with global Health Authorities; strategize and plan for Health Authority meetings; capture all communications via contact reports.
- Prepare information necessary for submissions (including initial INDs, IND amendments) in accordance with the regulations and relevant guidelines (domestic and international)
- Manage updates to CMC, nonclinical, and clinical information included in regulatory submissions (e.g., IB, protocols, safety reports)
- Prepare and maintain submission tracking documents and monitor status of the submission components
- Produce high quality regulatory submissions using electronic templates and support validation efforts for electronic databases that will be utilized for regulatory or quality assurance purposes
- Participate in Development Team meetings and provide regulatory support and guidance and manage day-to-day regulatory activities.
- Mentor/instruct and provide guidance to direct reports
- Assist other departments and submission authors in writing and editing submissions, in compliance with departmental and regulatory standards
- Research and provide analysis of current global regulatory laws and guidances, as needed
- Review and edit documents to ensure consistency and regulatory compliance
- Create and manage departmental SOPs related to Regulatory Affairs and operations
- Liaise with CROs which support publishing and medical writing activities
- Bachelor's degree in Life/Health Sciences required; Master’s Degree, Pharm.D, or Ph.D preferred
- Minimum of 5 years of experience in pharmaceutical / biotech
- Experience with eCTD structure and database management abilities including IND and NDA submissions
- Experience with documentation systems and with document review
- A strategic thinker with the ability to work both independently with minimal direction and within project teams, etc. to attain company goals
- Strong verbal and written communication skills
- Strong knowledge of current US and EU regulatory guidelines
- Ability to work well in a deadline-driven environment
- Experience in the oncology area is required
How to Apply
To apply, please submit your cover letter and resume to Recruiting@pmvpharma.com.
PLEASE, NO PHONE CALLS or AGENCIES
PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.