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Regulatory Clinical Trial Application Submission Manager

  • Job reference: 924845
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 11/04/2019

Orion Group are recruiting for a Regulatory Clinical Trial Application Submission Manager on behalf of our Multinational Pharmaceutical Client on an initial 8 month contract based in the Buckinghamshire Area

  • This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
  • The Regulatory Clinical Trial Application submission manager has experience in regulatory CTA submission regulations, requirements and will be 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.
  • In depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.

    Principal responsibilities include:
  • The Regulatory Clinical Trial Application submission manager will 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.).
  • The CTA submission manager will either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country. The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
  • The CTA submission manager manages 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.
  • If Clinical Research Organizations 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.

    DECISION-MAKING AND PROBLEM-SOLVING:
  • Identifies and proactively responds to issues, problems, or opportunities as it relates to the leading the CTA workgroup. Independently identifies the need for and collects information (from CTA working groups, GCO, HA-interactions, Local Operating Companies, Regional offices etc.) to better understand and resolve issues/challenges and seize opportunities.
  • Integrates information from a variety of sources, detects trends, associations, and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriate. Proposes relevant options for addressing problems or opportunities to supervisor.
  • Makes decisions independently for day-to-day activities of CTA workgroup. Decisions as they relate to changing processes that affect external stakeholders require consultation with supervisor and CTA Process Owner.


    Reporting Relationships:
    This function will report to either an Associate Director or Director-level supervisor, within Regulatory Submission Operations Management (RSMO).

    Education and Experience:
  • Bachelor's degree required or equivalent experience;
  • Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology.
  • Ideal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry.
  • An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.
  • Must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur.
  • Must have 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.
  • Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skills.
  • Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization.
  • Must be able to work independently, strong initiative. May have to work remotely from supervisor.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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Regulatory Clinical Trial Application Submissions Manager
  • Salary Negotiable
  • Job type Contract
  • Location High Wycombe, Buckinghamshire
  • Description Orion Group are currently recruiting for a Regulatory Clinical Trial Application Submissions Manager on a 6 month contract basis (with potential to be extended) for our Multinational Pharmaceutical