Regulatory Clinical Trial Application Submission Manager

Highly Competitive
  1. Contract
  2. Publishing & Submissions, CMC
  3. Switzerland
Basel, Switzerland
Posting date: 18 Nov 2019
RA.ML.26547_1574080686

A globally renowned pharmaceutical company is seeking to recruit a Regulatory Clinical Trial Application Submission Manager - Senior to their office in Switzerland. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment and provide real regulatory expertise.

Job Responsibilities:

  • Ensuring that the required regulatory intelligence is in place to comply with country-specific requirements.
  • Leading a cross-functional team (CTA Working Group [WG]) that will compile, publish, and produce Clinical Trial Authorisation Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
  • Submitting the CTAs directly to Health Authorities or facilitating the CTA submission by local personnel in their specific country.
  • Interacting with Health Authorities and acting as the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
  • Managing the Output Protection Process for assigned trials and ensuring that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
  • If Clinical Research Organisations are contracted to handle some (or all) aspects as outlined above, the submission manager will be responsible for liaising with and overseeing CRO staff, as required.

Skills and Requirements:

  • The Regulatory Clinical Trial Application submission manager has experience in regulatory CTA submission regulations and requirements.
  • In depth regulatory knowledge.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Manon Luflade at +44 2038540586 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-ML1

#RegulatoryAffairs

close