Senior Reg Affairs Consultant
- Employer
- Thornshaw Recruitment
- Location
- Dublin (County), Leinster (IE)
- Salary
- DOE
- Start date
- 20 Jul 2021
- Closing date
- 19 Aug 2021
View more
- Discipline
- Regulatory Affairs, Regulatory Writing
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Senior Regulatory Affairs Consultant
On behalf of my client, I am recruiting for a Senior Regulatory Affairs Consultant. The successful candidate will be responsible for the provision of regulatory advice to clients, preparation of critical regulatory documentation, representation of the company at meetings, and management of regulatory projects. This can be a full time or part time position.
Key Responsibilities:
- 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 9001:2015 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 Managing Consultant (or as appropriate to the project) is kept informed of the status of the work program.
- Keep up to date with, and as far possible anticipate, new or changing regulatory requirements in relevant territories.
- Support Real Regulatory in identifying information to target realistic business expansion opportunities.
- 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.
Qualifications/Experience:
- Bachelor’s degree in pharmacy, a life science or a biomedical discipline.
- In depth knowledge of the regulatory environment, guidelines and practice within EU.
- 10+ years 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.
- Excellent 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 and as part of a team.
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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