Associate Director CTA Operations, Global Regulatory Affairs (100%) (m/f/d)

Posted a month ago
Main Location
United States
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With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus.CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operatesCSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1600 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

For our location in Bern (Switzerland) or Marburg (Germany), we are looking for a

Associate Director CTA Operations, Global Regulatory Affairs (100%) (m/f/d)

Main Responsibilities and Accountabilities:

  • Lead a dedicated CTA Operations team to ensure timely clinical trial approvals globally in accordance with the Company strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
  • Ensure that regulatory strategic support and oversight for the Clinical Trials (CTs) is provided by the team at the high standards from study startup phase until Clinical Study Report submission.
  • Anticipate regulatory trends related to clinical trial applications to develop regulatory Intelligence capabilities and share lessons learned to ensure development of a first in class study strategy.
  • Further develop, execute and oversee CTA strategy.
  • Maintain and improve processes, procedures and systems which support the global management of CTAs.
  • Supervise global management of CTAs and ensure regulatory project management of CTAs overall as well as on study level.
  • Ensure management and oversight of the Contract Research Organizations (CROs) performing CTAs to ensure quality, timely approvals, and compliance.
  • Closely connect with Therapeutic Area Leads, Clinical Operations, to ensure globally aligned CTA submission strategy and CTA demand planning.
  • Ensure management and oversight of the CROs performing CTAs to ensure quality, timely approvals, and compliance.
  • Be a Subject Matter Expert for CTA related topics and ensure continuous process improvement and readiness for the implementation of the new EU Clinical Trial Regulation.
  • Responsible for the generation, maintenance and provision of metrics on workload as well as KPIs for key CTA activities and analyze consolidated data.
  • Assess the activity/performance of team members and/or subordinates by establishing objectives, and conducting performance appraisals for team members.
  • Will act as a Global Regulatory Study Lead (Lead CTA activities for all Clinical Trials during the entire study lifecycle; Perform CTA submissions in selected countries; Disseminate the CTA project status like CTA submission, CTA approval, CA questions to the concerned stakeholders, etc.).

Qualifications & Experience:

  • BSc/MSc degree or equivalent in life science, pharmacy, medical laboratory technology, or other health/medical related area. (Other degrees and certifications considered if commensurate with related quality management, regulatory or clinical research experience.)
  • As a guide, a minimum of 8+ years' experience in managing Clinical Trial Authorizations.
  • Demonstrated ability to problem solving and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
  • Experience in leading and managing a global team of professional staff.
  • Broad knowledge of regulatory requirements in key markets for obtaining Clinical Trial Authorizations
  • Knowledge of ICH guidelines/GCP, EU CTA regulation (CTR536/2014), related regulatory guidelines and experience in scientific/medical research.
  • Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
  • Excellent written and oral communication skills in English – German is a plus.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language.Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.

Worker Type:

Employee

Worker Sub Type:

Regular
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Associate Director CTA Operations, Global Regulatory Affairs (100%) (m/f/d)
CSL