Regulatory Clinical Trial Application Submission Manager

  • Contract type Temporär - until further notice
  • Place
    Allschwil
  • Reference 190726-3-1
  • Assignment start date asap
  • Sector Chemie & Life Sciences
  • Publication date 19.11.2019

You are passionate about Clinical Trials Applications submission activities and gathered a few years of experience in this field? For our client - a leading pharmaceutical company situated in Allschwil - we are contracting a:

Regulatory Clinical Trial Application Submission Manager

Your assignment

- Managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 mainly in the Pulmonary Hypertension therapeutic area)
- Responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial
- Ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team (CTA Working Group [WG]) that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)
- Submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given
country
- Responsible for interactions with Health Authorities, and act as the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs
- Manage the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system
- Responsible for liaising with and overseeing CRO staff, as required

Your profile

- Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry; knowledgeable with scientific terminology
- Minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry
- Experience in regulatory CTA submission regulations and requirements
- Understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements
- Excellent command of English, spoken and written
- Strong verbal and written communication skills, as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur
- Strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency)
- Ability to lead complex projects and a high degree of problem solving capability required
- Ability to lead multi-functional teams and build strong, productive relationships across the organization
- Ability to work independently, strong initiative
- A high level of self awareness and adaptability and strong impact and influencing skills

Interested?

This multifaceted project provides the opportunity to apply and increase your expert knowledge in one of the largest pharmaceutical companies worldwide. Also the possibility of contract extension is given. To submit your complete CV including diplomas and references just use the button ‘Apply'. We are looking forward receiving your application today!

Über Manpower
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