Regulatory Manager - Development
An exciting opportunity has arisen for a Regulatory Manager - Development at a leading biopharmaceutical organisation with extensive experience in discovering, developing, and manufacturing innovative human therapeutics. This opening is an exciting opportunity for applicants seeking their next career step within a truly global company with over 17,000 employees worldwide.
- Advising the GRT on regional considerations in developing strategy.
- Participating in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy (under general supervision).
- Providing regulatory guidance on regional regulatory mechanisms to optimise product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plans).
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
- Participating as a member of the Global Regulatory Team (GRT), Evidence Generation Team (EGT), Clinical Study Team (CST) and the Regional Teams.
- Acting as a contact with relevant regulatory agencies; documenting and communicating details and outcomes of regulatory agency interactions to GRT and relevant Management and Senior Management.
Skills and Requirements:
- Knowledge of relevant legislation and regulations relating to medicinal products and of regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
- Knowledge of drug development.
- Working with policies, procedures and SOPs.
- Cultural awareness and sensitivity to achieve results across both regional country and international borders.
- 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 Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.