RA Expert Freelancer

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a RA expert Freelancer for ResQup activities to support our projects in Israel.

You will be responsible for:

• Ensure adequate quality and meet regulatory and legal requirements.
• Developing of regulatory strategies for planned Clinical Trials.
• Preparing of regulatory documents for Clinical Trials, overseeing submissions of CTAs to regulatory authorities and ethics committees, management, and follow-up of CTAs in cross-functional cooperation and service providers.
• Supporting of service provider selection for Clinical Trials and management for regulatory aspects, participation in Clinical Trial Team meetings and specific external meetings (e.g., Investigator Meetings, meetings with regulatory authorities/ethics committees).
• Preparation and coordination of specific chapters of the product dossier (e.g., Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND).
• Providing regulatory documents for the eTMF to ensure readiness for audit/inspection during the Clinical Trial and for long-term archiving.
• Conduct and review of entries in Clinical Trial Registries (e.g., EudraCT) to ensure compliance with regulatory requirements.

About you:

• Bachelor's degree in relevant life science field.
• +3 years of work experience in a similar role for a pharmaceutical company or related field.
• Comprehensive Experiences as Regulatory Affairs Manager as well as experiences in Clinical Trial processes.
• Advanced knowledge in clinical research and in the conduct of clinical trials and regarding relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.).
• Professional verbal and written communication and great presentation skills.
• Advanced knowledge of medical or scientific terminology.
• Team-oriented style of working and flexibility and ability to support various clinical trials simultaneously.
• Availability to travel.
• Fluency in Hebrew and English.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.