The Company:
My client is a leading biotech company that discovers, develops, manufactures, and delivers innovative human therapeutics. They pride themselves with the ethical approach to drug discovery.
My client values results, people, and integrity. Their corporate goals are to launch a stream of products that will improve patients' lives, create an environment where the best people choose to work, deliver superior shareholder returns compared to our industry peer group, maximize the value of each franchise, and to be a good corporate citizen in the communities where our staff live and work. It is the incorporation of these values and aspirations that have made this organisation an industry leader.
This company is continually evaluating new technologies to bring products to market. It is their constant commitment to improvement that gives them the edge in creating the highest quality clinical trials.
The Role:
On this occasion, my client is looking for a Regulatory Affairs Manager to join their team located in Brussels. As a Regulatory Affairs Manager you will be responsible for activities related to submissions of International Clinical Trials. You will have the central liaison function between CROs and the Clinical Study Team.
Responsibilities:
-Partner with other functions, including local Global Clinical Site Management staff, to coordinate cross functional activities and interactions
-Partner with CRO staff to ensure understanding of local regulations governing clinical research in these countries
-Partner with CRO staff to document and maintain country-specific Clinical Trial Application (CTA) filing, safety reporting, import/export, clinical labeling, and other local requirements in appropriate Amgen systems
-Initiate CTA creation process and schedule/lead regional study kick-off meetings based on receipt of signed Work Request Form(s)
-Ensure all CTA filings are completed according to agreed submission timelines
-Ensure timely and effective maintenance of clinical trial approvals throughout the lifecycle of each clinical study
Requirements:
-MSc in a Science or a Business related subject
-3 years of experience in a Regulatory Affairs role
-Experience in a Team Leadership role
-Minimum of 5 years in biopharmaceutical/ clinical research
-Experience in Development (CTA) in the biotech or pharmaceutical industry
-Great attention to detail with incredible communication skills
This is an excellent opportunity to join the multinational environment of a leading and expanding biotech company.
Key Words: Regulatory Affairs Project Manager, CTA, Clinical Trial Applications, Drug Development, International Regulatory Affairs
Nikolay Dimitrov
Pharmaceutical Division
Tel:
+44 (0)20 7255 6665
+33 (0)170807489
+49 (0)69 222 22 888
+41 (0)44 580 3717
Email: Nikolay.Dimitrov@secpharma.com
Web: www.secrecruitment.com
