Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Regulatory Affairs Associate

Company: SynteractHCR Deutschland GmbH
Location: Rome, Italy
Reference: 26830
Closing Date: 03 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Regulatory Affairs Associate (f/m) Rome SynteractHCR is an international CRO located in EU, RUS, US and South America. As we are growing we are looking for a dedicated Regulatory Affairs Associate to join our Team in Italy. We offer you a challenging and rewarding job opportunity in a fast moving, flexible environment and a highly motivated team.   Your Tasks Submission and coordination of regulatory applications of clinical trials to authorities and ethics committees (e.g.

Requirements:

Regulatory Affairs Associate (f/m) Rome

SynteractHCR is an international CRO located in EU, RUS, US and South America. As we are growing we are looking for a dedicated Regulatory Affairs Associate to join our Team in Italy. We offer you a challenging and rewarding job opportunity in a fast moving, flexible environment and a highly motivated team.

 

Your Tasks

  • Submission and coordination of regulatory applications of clinical trials to authorities and ethics committees (e.g. clinical trial application, end of trial notification and report submission)
  • Compilation, review and assessment of all documents required for clinical trials, e.g. study protocol, patient information and product labelling
  • Support Regulatory Affairs Manager by preparing core dossiers
  • Ensure that applications are conducted according to local and international requirements/procedures (ICH-GCP, applicable local law and guidelines, applicable SOPs)
  • Assist with query reply to authorities and ethics committees
  • Attend project team meetings
  • Prepare regulatory documents for translation
  • Assistance with regulatory intelligence by monitoring the local and global regulatory environment and providing regulatory summaries
  • Collaboration with Clinical Operations, Safety and other internal departments

 

Your profile

  • Bachelor's degree in life sciences, business or a related field of study
  • Regulatory Affairs experience in a company dealing with clinical trials
  • Strong understanding and knowledge of local requirements of Ethics Committees and Competent Authorities submission procedures on clinical trials according to international and national laws and guidelines
  • Proficiency in MS Office and regulatory databases
  • Effective verbal and writing skills (Italian / English)

 

 

To apply

Have we sparked your interest? Then we are looking forward to receiving your application! Please apply through our homepage synteracthcr.com and state your earliest start date/notice period and your desired salary. If you have any questions regarding the position please contact antonia.schultzeynteracthcr.com

 


Apply for this job: Regulatory Affairs Associate

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

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.