Regional Regulatory Hub Coordinator EAEU Alignment
An internationally renowned pharmaceutical organisation is seeking to hire a Regional Regulatory Hub Coordinator EAEU Alignment for their office in the UK. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
- Ensuring uncompromised compliance and embracing corporate culture.
- Supporting EAEU dossier harmonisation activities in alignment and partnership with key stakeholders to ensure a submission ready dossier.
- Closely collaborating with the EAEU regional regulatory hub strategist to ensure alignment with any ongoing regulatory activities across the respective countries.
- Ensuring timely communication of any issues.
- Actively managing and tracking project timelines and deliverables.
- Supporting, planning, and monitoring activities, updating timelines when necessary, and communicating changes to the relevant partners.
- Liaising with manufacturing sites for obtaining supporting documents as needed.
- Supporting right first-time approvals.
- Reviewing submission packages for completeness as needed.
- Maintaining systems and databases per internal SOPs and policies.
- Ensuring training completion as per the assigned curriculum.
Skills and Requirements:
- Bachelor's degree or equivalent, i.e. degree in Chemistry, Pharmacy, or a related life science.
- Prior experience in the pharmaceutical industry in Regulatory Affairs, Conformance, or Compliance.
- Experience in regulatory affairs, preferably in human medicines - minimum 3 years of experience.
- Knowledge of European submission and product lifecycle management processes.
- Demonstrated experience of proactive and effective delivery in a matrix environment.
- Experience with Project Management is beneficial.
- Sound knowledge of the European regulatory environment.
- Good knowledge of CTD Module 3 and respective lifecycle processes.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Nuhom Sudsok at +44 203 871 8093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.