Summary: The successful candidate will lead and direct the development and execution of worldwide regulatory strategies for Aravive’s products. The VP Regulatory Affairs will provide expert analysis and evaluation of all regulatory information, recommend approaches for resolving risks and improving regulations. The candidate will also be accountable for effective regulatory submissions and communications/meetings with regulatory authorities.
Job Title: VP Regulatory Affairs
Reports to: CMO
Employment Type: Full-Time
FLSA Status: Exempt
- Advise internal clinical, non-clinical, quality and CMC departments on regulatory impact of development decisions
- Work with Quality Assurance to ensure systems are maintained and in compliance
- Communicate requirements and compliance obligations under applicable laws and regulations in the US and outside the US
- Maintain regulatory affairs infrastructure including development of departmental policies and procedures
- Direct submissions (IND, NDA, MAA etc.) and approvals
- Lead contact with regulatory agencies for all communications and meetings.
- Lead and write the development and submission of documents to regulatory agencies which will ensure our development goals are of high quality and on-time
- Manage safety review processes and reporting of safety issues to the FDA
- Responsible for management of the Regulatory Affairs department budget
Required Skills & Abilities:
- Ability to work across all departments and proactively identifying potential issues and put in plans to mitigate/avert.
- Ability to write reports, business correspondence, and procedural manuals.
- Ability to effectively present information and respond to questions from groups of personnel, including members of the Board of Directors.
- Strong organizational skills.
- Detail oriented and accurate.
- Ability to multi-task and prioritize work assignments with no supervision.
- Ability to work collaboratively with team members.
- Medical, Dental, Vision, 401(k)
- Advanced degree preferred in a scientific discipline with at least 10 years of relevant regulatory experience; (B.S. or M.S. will be considered with at least 10 years of experience)
- Demonstrated success in communication and negotiation with the FDA
- Experience in collaborating with and managing outside partners and vendors
Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.
Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer and fibrosis. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.
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