Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): Negotiable
Senior Regulatory Affairs Associate Location: Berkshire Want to work with a rapidly growing CRO and gain experience within many different Regulatory and therapeutic areas?
Senior Regulatory Affairs Associate
Salary: Dependant on experience + a competitive benefits package
Want to work with a rapidly growing CRO and gain experience within many different Regulatory and therapeutic areas?
Want exposure to ethics committee submissions?
Do you want individual training and development throughout your career to nurture your progression with the company?
An exciting CRO with a global presence is seeking a talented individual to join their Regulatory team to focus on Clinical Trial Applications. Reporting to a well-liked manager, this is an ideal team in which to develop a detailed understanding of CTAs, with the opportunity to work on high volume of submissions. The department is very friendly and values a collaborative team spirit.
The ideal candidate will have Regulatory Affairs experience either in a CRO or Pharmaceutical Company specialising in Clinical Trial Applications.
-Compile and submit Clinical Trial Applications to relevant bodies
-Ensure reliability of Clinical Trial Data
-Assist with training and mentoring of Regulatory Affairs internally
-Assists management with ensuring departmental awareness and compliance of regulatory and ethical requirements
-Create and maintain regulatory templates for submissions
-Follow SOPs relating to Technical Writing and Regulatory Affairs
-Clinical Trials Regulatory Affairs experience, ideally 2-3 years
-Demonstrable knowledge of Regulatory Procedures
-Understanding of GCP
-Strong communication and English language skills
-Degree educated, ideally within a Scientific or Healthcare field
-Ethics committee submissions experience/exposure is also beneficial
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.
Keywords: Regulatory, Affairs, Reg, Associate, Officer, Senior, CTA, CTAs, Clinical Trial, Clinical Trials, Clinical Trial Application, Clinical Trial Applications, MRP, DCP, National, Centralised, Procedures, SOP, Technical, Writing, Medical Writing, GCP, Pharmaceutical, Pharma, CRO, Consultancy, Lifescience, Biotechnology, Biotech, Medical Device, Oncology, Immunology, Neurology, Cardiovascular, Virology, Dermatology, Gastroenterology, Consumer, OTC, Prescription, EMEA, EU, Europe, UK, London, Middlesex, Berkshire, Hertfordshire, Bedfordshire, Surrey, Buckinghamshire, Uxbridge, Maidenhead, Slough, High Wycombe, Marlow, Regulatory Professionals, Reg Pro, #RegPro
3rd floor 33 Blagrave Street Reading
|Tel:||+44 (0)118 9522 797|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.