CTA/IND Project manager-Submission Delivery Excellence-Investigational, position holder(s) will be accountable for managing teams of Regulatory Submission Delivery professionals or as individual contributor in end-to-end processes to meet GSK's Investigational Drug Developments and Regulatory compliance obligations.

The position holder will act as an SME between GRO and GCO on operational topics related to Investigational Drug Development processes.

This position involves influencing stakeholders within and beyond GRA and driving harmonization and business change activities within the function, in addition to ensuring on time and quality delivery of submissions for R&D

development projects.

This role provides Regulatory management to link the business mission, strategy, and required processes to fulfil GSK s obligations with Health Authorities related to Regulatory submissions and will contribute to driving continuous

improvement and innovation of GSK Regulatory systems and processes.

The Program Manager will work collaboratively with stakeholders to agree on priorities and implementation timelines for Regulatory submissions globally to maximize the business value from a GSK perspective while

meeting Regulatory Authority requirements.

The Program Manager may provide line leadership for a team of direct reports in multiple locations globally.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

• May oversees a team of ~5-12 Regulatory professionals who will be responsible for the following, along with other value-added tasks as agreed with customers and leadership:

• Leveraging detailed submission requirement knowledge and technical capabilities to deliver fit for

  purpose and quality submission packages per agreed schedules.

• Preparation of CTA packages (EU & Non-EU) including authoring of the EU Application forms and

  Market Specific documents, and compilation with other submission components (IB, protocol, IMPD etc.)

• Preparation and delivery of submission packages for CTA amendments, EU End of Trial Notifications (EOTN) and EU Study Summary submissions.

• Plan and project manage the authoring and compilation of New US INDs with clinical, Regulatory and R&D Project team members.

• Precisely and consistently following Regulatory System processes which are aligned to GRA SOPs, Work Instructions, and How to Guides.

• Maintains a Patient Focused mindset while driving the implementation of more efficient e2e 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 SLAs and assessing individual and team performance.

• Participates in defining WoWs in conjunction with Stakeholders with a focus on continuous improvement,

  identification and implementation of automation opportunities, and compliance with Regulatory authority

  requirements.

• Partners 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.

• Responsible for ensuring proper training for staff and resourcing of deliverables.

• Serves as SME on Written Standards updates and continuous improvement initiatives, when required.

• Maintains awareness of emerging Investigational regulatory requirements across regions in scope of role

Why you?

Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment

• Experience in Pharmaceutical Regulatory Affairs with global regulatory procedures and submission requirements.

• Knowledge of global regulations and standards for regulatory applications.

• Ability to lead submission delivery activities within a Regulatory Operational team.

• Capable of working independently or leading a team to ensure timely project delivery.

• Project Management skills managing multiple activities across various sites.

• Ability to add value in matrix teams within a global organization.

• Ability to implement new processes and quality initiatives with relevant controls.

• Guide and advise Regulatory project teams on Regulatory Investigational submissions.

• Familiarity with Regulatory Submission Management and connections between regulatory systems.

• Assess and interpret Regulatory Requirements with Business Process Owners to develop solutions.

• Ability to work with minimal supervision.

• Potential for line management of staff.