Hobson Prior are seeking an accomplished professional to provide Regulatory Support to a global pharmaceutical business that specialises within the exploration and production of innovative pharmaceutical treatments and healthcare products.
- Cooperate within the client’s regulator and administrative activities for the product line in and outside of Europe.
- Oversee the production of data-packages due to Regulatory Authorities.
- Support the planning, production and follow-up of MAAs and of life-cycle regulatory activities for the DTP vaccines.
- Cooperate with the internal stakeholders for the preparation of documents as part of the regulatory dossiers/data-packages to meet submission deadlines.
- Monitor all regulatory aspects of the product safety and pharmacovigilance commitments.
- Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc.
- Ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects.
- Ensure each dossier/data-package submission is planned adequately.
- Ensure the tracking of relevant correspondence with Authorities and Local Operating Companies.
- Analytical capacity
- Good organizational skills
- Flexible work approach; enjoys a varied working day
- Teamwork and collaboration
- Can work under stress and to deadlines
- Scientific University Degree
- Regulatory background
- Knowledge of EU regulations
- Excellent oral and written English
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.