Company: Regulatory Professionals
Closing Date: 30 Dec 16
Type: Full Time
Salary (£): Negotiable
Study Start Up & Regulatory Manager - Italy Looking to cover global CTA submissions as a CTA Lead? Do you see line management as the next step in your career? Do you want to be a Subject Matter Expert within SSU & Regulatory Matters?
Study Start Up & Regulatory Manager - Italy
Looking to cover global CTA submissions as a CTA Lead?
Do you see line management as the next step in your career?
Do you want to be a Subject Matter Expert within SSU & Regulatory Matters?
Job type: Permanent
Location: Milan, Italy (with up to 2 days home working)
Salary: Highly competitive
Reference Number: J23911
My client is a full- service clinical research organisation, providing the full range of Phase I-IV clinical development services for the world's pharmaceutical, biotech and medical device industries. This organisation has business that spans across six continents, and are looking to strengthen their Ethics and regulatory department in the UK.
As a member of the Study Start Up team you will cover a wide variety of therapeutic areas and phases.
- Work within various areas of site start-up such as site activation, regulatory, submissions, site contracts or regulatory records
- Client facing- ensuring customer/client requirements are met
- Leading projects regarding clinical trial submissions to CA, LEC and CEC
- Business development- involvement in bid defences
- Act as the Subject Matter Expert in SSU & Regulatory functions
- At least 6-7 years experience in SSU/ Clinical Regulatory
- Ethics Committee submission experience in multiple countries
- Regulatory Authorities submission experience in multiple countries
- Site Contracts oversight experience
- Ideally line Management experience
If you are interested in this role please email your CV to Adam@regulatoryprofessionals.com or call Adam Taher on +44 (0) 1189 522797 to discuss further.
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.
Key words: Regulatory, Regulatory Affairs, SSU, Study Start Up, Manager, Regulatory Affairs Manager, Clinical, CTA, Ethics Committee, Milan, Italy, home working, Competent Authorities, Site Activation, Clinical Operations, Clinical Research
3rd floor 33 Blagrave Street Reading
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