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Regulatory CTA Submission Manager

  • Job reference: 934459
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 11/03/2021

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.

Successful candidates for this position must have: in depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.

Principal Responsibilities

  • 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 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 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 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.
  • 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.
  • Works independently to achieve team goals with high level of autonomy. Routinely updates supervisor on work status and engages supervisor when management support / escalation is required to address issues.

Reporting Relationships:

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

  • Regulatory Affairs staff within the global, regional, and therapeutic area organizations
  • Cross-functional CTA working group team members
  • Local clinical trials staff
  • Health Authorities
  • CROs (if applicable)

Experience /Education Requirements:

  • 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.

#Pharmaceutical #multinational #Clinical #Regulatory #CTA

For more information on this role, call Denise Cagney on +44 (0) 203 994 4695 / +353 86 0327943 or email Denise.Cagney@orioneng.com for a completely confidential chat about this role. REF: 934459


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.