Regulatory Affairs Specialist, Clinical & CMC
|Contact Name:||Larry O’Leary|
Our client seeks a Regulatory Affairs Specialist for the provision of regulatory advice to clients, preparation of critical regulatory documentation, representation of the company at meetings and management of regulatory projects.
The successful candidate will be integral to the success of client's key projects from a Regulatory perspective. The ideal person fit will be a self-starter, capable of working independently and as part of a team. The role will be based in Dublin, with some flexibility to work from home.
This is a part-time permanent role with initial 6 months probationary period.
Responsibilities of Regulatory Affairs Specialist:
- Development and execution of proactive and pragmatic regulatory, clinical and compliance support strategies to support company's corporate objectives.
- Designing, planning, implementing and delivering training on quality and risk management systems.
- 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.
- Ensuring the documentation meets relevant regulatory requirements.
- Evaluating classification, technical, preclinical and clinical data for regulatory submissions.
- Project management of client projects and representation of the company and client companies at meetings.
Person spec for Regulatory Affairs Specialist:
Bachelor's Degree qualification in in pharmacy, a life science or a biomedical discipline.
5+ years' experience in an RA role within an FDA and / or ISO9001:2000 regulated pharmaceutical environment.
Excellent project management, organisation and multi-tasking skills.
Superb attention to detail and accuracy.
The ability to establish priorities from among a number of demands and to handle interruptions effectively.
Flexible and willingness to adapt with business requirements.
Works to the highest professional, ethical and moral standards.
Please contact Larry on 01-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie