Excellent opportunity for a Regulatory Affairs professional to manage Clinical Trial Applications
Over de functie
Yacht Life Sciences has a vacancy for a Regulatory Submission Manager at our client in Leiden, an international pharmaceutical company. This position can also be performed by a freelancer (ZZP).
This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
The Regulatory Submission Manager has experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
Successful candidates for this position have: in depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.
- Ensure required regulatory intelligence is in place to comply with country-specific requirements
- Leads a cross-functional team (CTA Working Group [WG]) that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)
- Submits the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country
- Responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs
- Manages the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system. If Clinical Research Organizations are contracted to handle some (or all) aspects as outlined above, this person will be responsible for liaising with and overseeing CRO staff, as required.
- Identifies and proactively responds to issues, problems, or opportunities as it relates to the leading the CTA workgroup.
- Independently identifies the need for and collects information (from CTA working groups, GCO, HA-interactions, Local Operating Companies, Regional offices etc.) to better understand and resolve issues/challenges and seize opportunities.
- Integrates information from a variety of sources, detects trends, associations, and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriate.
- Proposes relevant options for addressing problems or opportunities to supervisor.
- Makes decisions independently for day-to-day activities of CTA workgroup. Decisions as they relate to changing processes that affect external stakeholders require consultation with supervisor and CTA Process Owner.
- Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required
- Knowledgeable with scientific terminology
- Ideal candidate would possess a minimum of 4 years experience within regulatory affairs (RA) in the pharmaceutical industry. Please note we are NOT considering candidates with Clinical Trial Ops background; Regulatory Affairs experience is required
- An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required
- Must have strong EN communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur
- Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency).
- Ability to lead complex projects and a high degree of problem solving capability required
- Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skills
- Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization
- Must be able to work independently, strong initiative
We will offer a competitive benefits package in line with the seniority of the position. This is a position for 5.5 months for 4 or 5 days per week, with the potential for extension. The position can also be performed as a freelancer (ZZP).
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
A global biotechnological company that develops, acquires, and commercializes pharmaceutical products and biopharmaceutical therapies.
Voor meer informatie neem je contact op met Gyöngyvér Lukács via telefoonnummer +31 0610317714
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Uiteraard staat deze vacature open voor zowel mannen als vrouwen.