Do you have a Master's degree in Management, Life Sciences or equivalent, with relevant experience in Regulatory Affairs and working knowledge of ICH and GCP guidelines? Then we may have your dream job! Let's connect!
Job Description
The Regulatory Coordinator is responsible (primarily or in supporting role) for all activities related to the submissions to Ethics Committee(s) and Regulatory/Competent Authorities. In addition, responsibility includes creating, initiating,coordinating, monitoring and maintaining clinical study site documentation.
Responsibilities
Ethics Committee Activities
- Solicit input from clinical teams on assigned synopses, protocols and Informed Consent Documents (ICDs)
- Ensure the accuracy of managed ICDs and their translations, as well as related regulatory documents for assigned protocols
- Responsible for preparing CTA submissions to Ethics Committee(s)
- Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidance's and regulations/laws
- Coordinates with PCRU Pharmacists, RegCMC and Dev Ops colleagues to ensure timely and accurate submission of studies to the Ethics Committee(s)
- Lead the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), and ensure communications to EC
- Ensure end of study reports and annual reports are provided in time to Ethics Committees
Regulatory Authorities Activities
- Responsible for preparing CTA submissions to Competent Authorities
- Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidance's and regulations/laws
- Coordinates with PCRU Pharmacists, RegCMC and Dev Ops colleagues to ensure timely and accurate submission of studies to the Competent Authorities
- Lead the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), and ensure communications to CA
- Ensure end of study reports are provided in time to Regulatory Authorities
Other Activities
- Responsible for study-specific tasks such as site registration in CTMS/Oracle Siebel and Shared Investigator Platform (SIP), QC and filling of study documents in PTMF as well as maintenance and archiving of study files (ISF)
- Act as SME for SOP updates and review within the functional line
- Provide oversight on specialized regulatory related PCRU projects
- Liaison to the project teams for studies scheduled in the PCRU to provide inputs on regulatory aspects
- Develop knowledge of the GDPR and optimize its implementation at the PCRU
- Lead PCRU teams in accomplishing business needs and resolving issues
- Give input in PCRU documentation to facilitate positive attitude and trust of participants
Requirements
- Bachelor's degree in management, Life Sciences or equivalent, with relevant experience in Regulatory Affairs
- A Master in related field
- Independent and team player
- Accountable, proactive and leadership skills
- Strong organizational skills, multiple projects flexibility and able to work in fast pace environment
- Detail oriented,strong communication skills
- Strong IT skills: advanced use of MS Office package
- 5+ years of experience in pharma, of which at least some years in a regulatory environment
- Working knowledge of ICH and GCP guidelines required
- Strong understanding and knowledge of regulatory aspects of drug development
- Languages : Trilingual FR/EN/NL
- Scientific / Medical Knowledge: Understanding of basic clinical pharmacology principles, with ability to review emerging safety and efficacy profile of a drug candidate and recognize potential serious adverse effects;Demonstrated understanding of the complexities and recent developments in exploratory research.
- Participates to the successful study conduct of PCRU studies in accordance with ethical, legal, and moral standards,
- Good Clinical Practices, Good Laboratory Practices, PCRU management requests, Clinical Development and operations (CD&O) and Global product Development (GPD) goals.
- Existing right to work in Europe required
Benefits
- A full-time position
- A balanced salary package based on your capabilities and experience.
Vacancy number: 18485
