Strategic Regulatory Affairs Specialist, Clinical & CMC
|Contact Name:||Larry O’Leary|
Our client seeks a Strategic Regulatory Affairs Specialist for the provision of regulatory support, preparation of critical regulatory documentation, representation of the company at meetings and management of regulatory projects. This role will be based in Dublin, with flexibility to work from home.
This successful candidate will take projects from beginning at the early stages providing key regulatory strategy and activities that take a concept right through development to product commercialisation.
Additionally this hire will be the Subject Matter Expert supporting clinical trial regulatory activities globally, providing the liaison with EMA and EU agencies, in the provision of varied projects, i.e.; ATMP Classifications, Orphan Designations, Scientific and Protocol Advice with EMA and national agencies, PIP applications, PRIME applications, etc.
This hire will be integral to the success of the company’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.
Key responsibilities and requirements:
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 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.
Bachelor’s Degree qualification in in pharmacy, a life science or similar discipline.
4+ years’ experience in an RA role within an FDA and / or ISO9001:2000 regulated pharmaceutical environment.
Excellent project management, organisation and multi-tasking skills.
The ability to establish priorities from among a number of demands and to handle interruptions effectively.
Superb attention to detail and accuracy.
Flexible and willingness to adapt with business requirements.
Works to the highest professional, ethical and moral standards.
Please phone Larry on +353 1-2302400 / email@example.com
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
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