Location: Company offices in Gothenburg (remote work part time possible)
Position type: Full-time
Start date: As soon as possible
VERIGRAFT is a pioneering biotech company developing personalized tissue therapies. Our lead product, P-TEV, is advancing into Phase II clinical trials for Chronic Venous Insufficiency (CVI) in Europe and the United States.
We’re now seeking a Clinical RA/QA Manager to progress our clinical trials and to move VERIGRAFT’s products to market authorization as efficiently as possible while meeting quality and regulatory standards. We are looking for a person with a solution-finding mindset that can most efficiently navigate the regulatory landscape. In short, we seek a person that can find the leanest way to accelerate our regulatory path to the market.
Your role
The following responsibilities are included in the role of Clinical RA/QA Manager:
Regulatory Affairs (RA):
- Develop and implement efficient regulatory strategies for our tissue therapies (ATMP) in both EU (EMA) and U.S. (FDA) jurisdictions
- Manage processes with regulatory authorities (EU and USA)
- Optimize clinical trial design for Rapid Approval and market acceptance
Quality Assurance (QA):
- Take responsibility for the Quality Management of all clinical activities and outsourced manufacturing
- Create and implement written standard procedures for Sponsor Oversight, including Quality Assurance of our CRO and CMO, according to ICH GCP E6
- Responsibility for the sponsor part of the TMF
- Ensure compliance with ethical standards and data integrity
Collaboration:
- Work closely with the Clinical Trial Coordinator to align quality and regulatory frameworks with operational plans, reporting to the CTO.
- Act as primary RA/QA contact for external partners, and regulatory bodies
Qualifications & experience
- Bachelor’s or master’s degree in life sciences, pharmacy, biomedicine or related field
- Previous RA/QA experience within clinical development of ATMPs or advanced biologics
- Proven track record of successful clinical submissions to EMA and/or FDA
- Previous hands-on experience with Sponsor Oversight according to ICH GCP E6
- Previous hands-on experience with market authorization of ATMPs is a plus
- Excellent written and verbal communication in English; other EU languages are a plus
- Willingness to travel to clinical sites, CRO’s and regulatory meetings
Personal qualities
- Strategic thinker who can balance speed to market with robust compliance
- Detail-oriented with a strong sense of accountability
- Collaborative team player, comfortable interfacing across functions and cultures
- Proactive problem-solver who thrives in a fast-paced startup environment
What we offer
- A key role at the intersection of RA/QA and the cutting-edge of regenerative medicine
- A dynamic, supportive team committed to transforming patients’ lives
- Flexible work arrangements and the opportunity for international travel
- Competitive performance driven compensation and benefits package
Want to join us?
Please email your CV and a personal letter to jobs@verigraft.com. For more information on VERIGRAFT and our pipeline, visit www.verigraft.com.