Shreeya Patel is working with a global management consultancy to help recruit 3 Regulatory Affairs Managers to join their expanding team in Berkshire on a permanent basis.
This is a fantastic and exciting time to join an experienced Regulatory team with an employer that enables you to make a difference. They offer a variety of formal and informal training programmes at every level to help you to acquire and build the essential and relevant skills faster.
As Regulatory Affairs Manager you will support the Regulatory Operations team in the generation of electronic submissions.
- Conduct regulatory reviews of technical summaries, quality, nonclinical and clinical study reports, and administrative documents for regulatory filings.
- Assist with the filings and approval processes for MAA products within all types of European Regulatory Procedures. Also with MAAs outside of the EU Member States including and not limited to Switzerland, Australia and South Africa
- Assist with the assembly of Common Technical Document (CTD) and electronic CTD filings
- Assist with providing regulatory expertise on of MA life cycle management (variations, renewals, labeling, and line extensions
- Provide mentoring support to publishing associates and specialists.
- Assure submissions adhere to EU and ICH guidelines and working knowledge of key health authorities in the EU including the EMA, Germany and UK
- Interact with clients regarding regulatory issues.
- Interact with other European Team Members in supporting the growth of the European Organisation
- The successful candidates for these Regulatory Affairs Manager roles will have:
- Significant experience in the pharmaceutical industry
- Practical experience with electronic submissions, preferably eCTD
- Knowledge and/or experience in the submission of CTAs; and the planning, compiling, filing, and approval of MAAs in all EU Regulatory Procedure Types
- Knowledge and experience with MAA Pre-submission filing activities, including HA Meetings
- Compile CTA submissions (original applications and amendments, etc).
- Project management skills
- Knowledge of the European Regulatory and EU/ICH Guidelines
- Ability to work in a geographically spread team environment
- Supervisory skills
- Ability to work on numerous projects (multi-task)
- Ability to travel
- MS Office skills
- Attention to details
How to apply:
For more information or to apply for this role please contact Shreeya Patel on 01438 743047 or email email@example.com