Job description
they develop drugs, devices and diagnostics that improve and save human life.
Pearl Pathways supports companies in their development, manufacturing and
marketing of these products. Our mission is to deliver superior services that
effectively enable our clients to accelerate life science product development.
Pearl Pathways’ service offerings include:
Position
Regulatory Advisor
Job Description
The Regulatory Advisor is responsible for creating regulatory strategies, leading global
health agency filings, and managing FDA communications on behalf of Pearl clients for
devices and biopharmaceutical products. This role has the day to day responsibility for
leading client projects to support product development, submissions, and post marketing
activities.
Responsibilities include:
• Develop regulatory strategies for global submissions
- Lead regulatory submissions: IND, IDE, NDA, BLA, PMA, 510k, etc…and their global
- Manage FDA and other global health authority face-face communications and via all other
- Write regulatory documents – for paper and eSubmission
- Lead cross functional teams across clinical, CMC, device engineering, quality, etc.. in
- Reports directly to Director of Quality/Regulatory
Training/Experience Requirements:
• At least 10 years drug OR device quality compliance experience.
- RAC certification preferred
- Bachelor’s degree required
Skills
• Strong technical background required
- Some experience in quality assurance roles or auditing preferred
- Track record of leading regulatory strategy and filings for bio-pharma and/or device
- Both drug and device experience a plus
- Mix of large sponsor company and small startup experience a plus
- Global filing experience preferred
- Ability to work autonomously
- Exceptional communication skills, both verbal and written
Send inquiries and your resume to recruiting@pearlpathways.com
Company Description
Pearl Pathways (www.pearlpathways.com) is a comprehensive life science product development services company.
Our experienced team is obsessed with expediting life science product development regulatory pathways. We have three
business units to serve our clients:
- Pearl IRB (www.pearlirb.com) is a full service commercial Independent Review Board that provides human
writing, site assessments, and monitoring services.
- Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance,
auditing services.
- Pearl IDEAS provides strategic product development assistance, third party vendor selection and management
To learn more, contact us at info@pearlpathways.com or visit us at
www.pearlpathways.com.
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