Cta/ind Submission Lead-submission Delivery Excellence-investigational

4 weeks ago


القاهرة, Egypt GSK Full time

**Site Name**: Poznan Grunwaldzka, Bengaluru Luxor North Tower, Egypt - Cairo, Mexico City Torre Mitikah, Mississauga Milverton Drive
**Posted Date**: Feb 13 2025

**CTA/IND Submission lead-Submission Delivery Excellence-Investigational**, position holder(s) will be accountable for Regulatory Submission Delivery professionals 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 submission lead 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.

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

**_ Why GSK?_**

**At GSK we offer a wide range of additional benefits**:

- Career at one of the leading global healthcare companies
- Hybrid work ( 2/3 days per week from the office)
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagemen



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