CTA IND Submission Lead

Key Responsibilities -

• Leveraging detailed submission requirement knowledge and technical capabilities to deliver fit for purpose and quality submission packages per agreed schedules.
• Preparation of Clinical Trial Application (CTA) packages (EU & Non-EU) including authoring of the EU Application forms and Market Specific documents, and compilation with other submission components (Investigator's Brochure (IB), protocol, Investigational Medicinal Product Dossier (IMPD), etc.).
• Preparation and delivery of submission packages for CTA amendments, EU End of Trial Notifications (EOTN), and EU Study Summary submissions.
• Planning and project managing the authoring and compilation of DSURs, new US Investigational New Drug applications and amendments (INDs) with safety, clinical, therapeutic groups, and other R&D project team members.
• Precisely and consistently following Regulatory System processes which are aligned to Global Regulatory Affairs (GRA) Standard Operating Procedures (SOPs), Work Instructions, and How to Guides.
• Maintaining a patient-focused mindset while driving the implementation of more efficient end-to-end processes, eliminating unnecessary handoffs and siloed responsibilities.
• Advocating and driving the use of Regulatory Systems with stakeholders and submission deliverable providers.
• Ensuring team members adherence to agreed Service Level Agreements (SLAs) and assessing individual and team performance.
• Participating in defining Ways of Working (WoWs) in conjunction with stakeholders with a focus on continuous improvement, identification, and implementation of automation opportunities, and compliance with regulatory authority requirements.
• Partnering with peer colleagues in Submission Delivery Excellence and the Regulatory Asset Oversight team to maximize resources and to identify and remove barriers that will prevent a successful outcome on submission delivery targets.
• Ensuring proper training for staff and resource delivery.
• Serving as an SME on written standards updates and continuous improvement initiatives, when required.
  Maintaining awareness of emerging investigational regulatory requirements across regions in scope of role.

Basic Qualifications -

• Has experience of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures, particularly those related to global submission requirements.
• Good knowledge of relevant regulations and standards relating to the submission of regulatory applications and drug development worldwide.
• Ability to lead the coordination of submission delivery activities as an integral member of a Regulatory Operational team.
• Ability to work well both independently and within or leading a team to ensure on-time delivery of objectives/projects.
• Demonstrated Project Management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers.
• Ability to work with and add value to matrix teams in a globally diverse organization.
  Ability to define and implement new processes and quality initiatives with an awareness of relevant controls and impacts.

Must have skills -

• Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment.
• Must be familiar with the overall concept of Regulatory Submission Management and the connections between various regulatory systems and associated processes.
• Must be able to assess and interpret Regulatory Requirements in collaboration with Business Process Owners to develop appropriate solutions to meet both system and business need.
• Should be able to work with minimal supervision.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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