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GlaxoSmithKline
CTA, IND Submission lead-Submission Delivery Excellence
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 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.
Posted 7 days ago
Project manager
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.
Finance Director
As Finance Director Egypt, you will provide financial leadership to GSK Egypt; partner with the General Manager and key stakeholders in setting and achieving financial targets for the business. You ll provide insightful financial analysis and input to optimize resource allocation and ROI for the business, and establish a robust financial internal control framework to ensure the compliance to the policy, statutory and tax regulations. Finally, you will directly manage and lead the Finance Department of GSK Egypt. Key Responsibilities Lead the development, preparation & presentation of strategic plans, budgets & forecasts for GSK Egypt Listed entity Review the operations of the businesses, making necessary analysis & recommendations to local management to enable delivery of financial targets Provide insightful financial and business input to decision making and evaluation of strategic options to optimize resource allocation and ROI. Provide key counsel to the General Manager on business issues Lead & manage the preparation of monthly, interim & annual accounts so that they are complaint with local & corporate statutory guidelines Manage credit control policies & working capital to optimize cash flow generated from operations Lead development of short, medium, and long-term plans for the business Provide product analysis /profitability for sales /marketing decisions Ensure rigorous review and challenge of funding proposals ensuring compliant practices and effective ROI Provide finance support to business cases and new launches Close liaison with the area team Development of talent within the GSK Egypt finance team Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor s degree in business administration, finance, or equivalent Minimum 10 years of experience in a multinational organisation Demonstrated experience in financial management and accounting theory & practices Demonstrate resiliency & adaptability to lead the finance function in a complex, marketing driven environment Proven leadership skills and team builder, with ability to motivate, coach & develop people Leverage accounting knowledge to assist attainment of business objectives Benchmark efficiency against other operations & recommend strategies Preferred Qualifications: If you have the following characteristics, it would be a plus: Master s degree in Finance Experience in the pharma industry
Posted 22 days ago
Any time
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On-site/remote
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