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Regulatory Affairs Consultant/Manager

Regulatory Affairs Consultant – International Clinical Services Organisation – Hertfordshire– £65,000 +

JOB TITLE: Regulatory Affairs Manager / Regulatory Affairs Consultant

LOCATION: Hertfordshire, Herts, Bedfordshire, Beds

COMPANY STATEMENT: This is an international clinical research and associated services company who are world leaders in their field and continuing to build on their outstanding reputation. Their presence in the market is bolstered by their excellent employee development scheme; they believe in lifetime development for all employees.


SALARY: £65,000+ Bonus, Private health, Pension, Life Assurance and more.


ROLE/DESCRIPTION:
This is an excellent opportunity for a senior Regulatory professional looking to take the next step in their career and push the boundaries of their current knowledge. You will need to come in as a key point of knowledge and provide effective regulatory consultancy and support for client projects and oversee the development and management of key client accounts.


• Provide advice on EU regulatory strategy and requirements for investigational and marketed products to pharmaceutical and biotechnology clients
• Lead/participate in specific projects as directed by the Regulatory Affairs Director
• Participate in client meetings and liaise with clients regarding ongoing projects
• Preparation, coordination and review of documentation in order to support regulatory submissions for both investigational and commercial medicinal products
• Liaise with regulatory authorities including the organisation of agency meetings and associated briefing materials

EXPERIENCE REQUIRED:
• Broad experience of EU regulatory affairs regulations to include, early and late phase development, Marketing Authorisation Application, line-extensions etc. Post-marketing experience is also desirable.
• Expertise in regulatory activities supporting development, e.g. clinical trial regulations across Europe including drug import/export, agency interactions including scientific advice meetings
• Proven experience preparing and submitting regulatory submissions and providing ongoing communication to EU regulatory agencies

i-PHARMCONSULTING.COM

TO APPLY

If you would like to discuss this vacancy further, please call Principal Consultant Lauren Bell-Misri on +44 (0)20 3189 2299, or email lbell-misri@i-pharmconsulting.com. If this role is not suitable, Lauren is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


KEY WORDS:

Regulatory Affairs Consultant, Regulatory Affairs Manager, Clinical research, Clinical trials, submissions, Marketing authorisations, CMC, eCDT, CTD, GMP, GCP, Pharmacovigilance, Drug safety

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