Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Senior Regulatory Affairs Specialist. Home-based, can be anywhere in Europe. £45,000 - £65,000 - flexible dependant on living costs relative to location + great benefits. Would you like a varied role, with opportunities to gain experience in a range of different projects
Senior Regulatory Affairs Specialist
Location: Home-based, can be anywhere in Europe
Salary: £45,000 - £65,000 - flexible dependant on living costs relative to location + great benefits
Would you like a varied role, with opportunities to gain experience in a range of different projects in different therapy areas?
Are you interested in home-based work?
Are you a Regulatory Affairs candidate with Ethics Committee and Competent Health authorities' submission experience?
A global CRO are currently looking for a Senior Regulatory Affairs Specialist, due to a significant increase in the number of projects they are working on.
This is an exciting opportunity with a company that work on a range of fantastic therapeutic areas including oncology, cardiovascular and CNS.
Your role will focus around compiling the full core packages for Clinical Trial Applications (CTAs) to Competent Authorities and Ethic Committees to support the projects carried out at all stages of the drug development cycle, which includes:
*Liaise with the relevant internal actors to plan, organise, compile, progress and submit regulatory submissions in a deadline-oriented environment.
*Monitor and carry out ethics committee submissions, dealing with approvals across the APAC region and other global territories
*Provide regulatory strategy input
*Stay on top of changing regulatory legislative requirements and maintain regulatory intelligence database
*Contribute to the writing of technical reports of specified regulatory submissions such as chemical, pharmacological, pharmaceutical and clinical
*Review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements
*Comply with relevant SOPs, ICH GCP and national regulations
*Deputize for the Regulatory Affairs Director as required
*Must have completed the full core package for Clinical Trial Applications and submitted it to Competent Authorities and Ethics Committees
*This means having done the full global submission yourself rather than sending it to local authorities to submit there.
*Previous experience within the pharmaceutical industry
*Bachelor"e;s Degree in Chemistry or Life Sciences, Nursing or equivalent experience
*Experience with the APAC region highly desirable
Other skills and abilities:
*Extensive organisational management skills
*Knowing any European languages is beneficial
*Strong interpersonal skills which can be utilised in a fast-paced, dynamic environment.
*Clear understanding of ICH GCP across all areas
*Good knowledge of EU Clinical Trials Directive
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to email this on to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 worth of vouchers of your choice.
Keywords: CTA, Clinical Trial Applications, homeworking, Europe, Ethic committees, submissions, strategy, Regulatory Affairs, Competent Authorities, Regulatory Affairs Specialist, Regulatory Affairs Senior Officer, Clinical, Local Health Authorities, Local Ethic Committee, ICH GCP, global submission,
3rd floor 33 Blagrave Street Reading
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