This position is responsible for the provision of regulatory advice to clients, preparation of critical regulatory documentation, representation of Real Regulatory and client companies at meetings and management of regulatory projects. The successful applicant will be integral to the success of clients key projects from a Regulatory perspective.
This can be a full or part time permanent role on satisfactory completion of the initial 6 months probationary period. The role can be based out of the UK or Irish office, some home working and client site working is a possibility. Candidates much be eligible to work in the UK and/or Ireland.
- Bachelor’s degree in pharmacy, a life science or a biomedical
- In depth knowledge of the regulatory environment, guidelines and practice within EU.
- Breadth of regulatory experience (4 years +) in drug development, MAA approval and post-licensing (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas).
- Experience with EU regulatory procedures (Clinical Trial Submissions, CP, MRP, national).
- Experience in the clinical development and/or biotech sectors are particularly desirable.
- Excellent English, and written and oral communication skills.
- Excellent project management, organisation and multi-tasking skills.
- Superb attention to detail and accuracy.
- Self-motivated, pro-active and capable of working independently, however can also work as part of a team.
- Computer literacy.
Essential Duties and Responsibilities:
Key responsibilities that the role will have include:
- Strategic and tactical input in development, post-approval and Life cycle management projects.
- Liaison with Regulatory Agencies, client companies and other stakeholders
- Input into technical documentation and process development
- Clinical Trial Applications (CTA)
- Marketing Authorization Applications (MAA)
- Active support of the Real Regulatory ISO 9001:2008 Quality System
- Project management
- Resource Planning
Other responsibilities will include:
- Foster constructive and professional working relationships with all contacts and actively pursue the progress of all projects and submissions.
- Ensure that the Regulatory Affairs Manager (or as appropriate to the project) is kept informed of the status of the work
- Keep up to date with, and as far possible anticipate, new or changing regulatory requirements in relevant
- Support Real Regulatory in identifying information to target realistic business expansion
- At the discretion of the directors of Real Regulatory, assist with any other functions as may be necessary to meet tight deadlines or react to unforeseen circumstances.
Mentoring of more junior staff
Relationship to other positions:
The role will report to the Managing Consultant.
How to apply:
If you wish to be considered for this role, please forward your C.V with cover letter to firstname.lastname@example.org
Closing date for applications is 31st March 2018.