Vice President, Regulatory Affairs & Quality Assurance
Vice President, Regulatory Affairs & Quality Assurance
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Vice President Regulatory Affairs & Quality Assurance is responsible for developing and executing global regulatory strategies aimed at the most efficient regulatory pathway and ensuring quality compliance for ORICs development programs. This position involves shaping and leading the long-term regulatory strategy and quality operations vision across all phases of development providing oversight in planning product development strategies (including nonclinical clinical and post-approval) overseeing the companys development pipeline from preclinical through commercialization interacting regularly with global regulatory authorities overseeing global regulatory submissions across multiple regions and building internal systems to support successful submissions of multiple IND/CTA/NDA/MAA/PMA applications. Further the Vice President Regulatory Affairs & Quality Assurance is responsible for building and mentoring a high-performing team while assuring that ORIC is compliant with federal and state legislation health authority regulations and guidances and driving a culture of quality and accountability across the organization.
DUTIES AND RESPONSIBILITIES:
- Provide oversight for global regulatory affairs in all major regions (North America Europe Asia Pacific Latin America) for all regulatory functions including Clinical Non-clinical Regulatory Operations and broad oversight for Regulatory CMC and Regulatory Diagnostics
- Represent ORIC and act as a company spokesperson (or delegate with oversight) in communications with regulatory authorities
- Ensure highquality and timely regulatory submissions (IND/CTA/NDA/MAA/PMA) in compliance with all applicable regulatory requirements and in alignment with corporate goals
- Provide strategic input on all regulatory activities in support of product development plan lifecycle management and post-approval planning
- Supervise and develop regulatory direct reports and quality affairs reports
- Provide management with regulatory due diligence advice for potential new product opportunities
- Grow corporate project and industry knowledge
- Analyze and communicate current Regulatory issues and information to senior management and other departmental personnel.
- Oversee stage-specific development implementation and monitoring of all GXP activities via management of the Quality Affairs Department
- Ensure GXP compliance across clinical operations CMC and supply chain functions
- Lead preparation for and management of regulatory inspections including pre-approval inspections
- (PAIs)
Qualifications :
QUALIFICATIONS:
- Advanced degree (PhD PharmD MD or MS) in a life sciences or health-related discipline desired
- At least 15 years of biopharma regulatory and quality experience with 10 years focused on oncology and late-stage development including post-regulatory approval product launch experience
- Previous experience directing and coordinating FDA and other Health Authority interactions
- Demonstrated success leading major regulatory submissions (NDA/BLA/MAA) through approval
- Strong experience with GXP compliance and building quality systems (QMS) in a development-stage and/or commercial environment
- Experience with electronic filings (e.g. eCT)
Additional Information :
The anticipated salary range for candidates is between $300000-$375000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title type and length of experience within the job type and length of experience within the industry education etc.
ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristic.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
