Submission Delivery Manager, Submission Technical Support Team

The Submission Technical Support Team Manager will hold managerial responsibility for direct reports and is accountable for the completion of assigned tasks within their domain. Additionally, the Manager serves as the point

of escalation for matters concerning resource allocation or quality considerations.

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 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.

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

• Manage HR aspects for a team of direct reports including recruitment.

• Manage workload within assigned team and work with other managers within functional area to address

• resource challenges.

• Provide peer review and quality check support as requested and able.

• Serve as point of escalation for team members.

• Advise and assist authors with more complex or non-routine assignments.

• Participate in quality or continuous process improvement activities related to area of responsibility or as requested.

• Maintain appropriate organizational networks.

• Independently and confidently executes agreed assignments strategy.

• Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products/registration data management/submission format to expedite submission, review, and approval of global applications.

Why you?

Qualifications and Experience Required

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

Educational Background:

• Degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment.

Interpersonal and Communication Skills:

• Strong interpersonal and communication skills, with the ability to build and maintain relationships and effectively manage team dynamics.

Regulatory Affairs Experience:

• HA experience in 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 worldwide.

Project Management:

• Demonstrated project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers.

• Ability to lead and coordinate submission delivery activities as an integral member of a Regulatory Operational team.

Teamwork and Leadership:

• Ability to work well both independently and within, or leading, a team to ensure on-time delivery of objectives/projects.

• 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.

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 engagement, holiday benefit)

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible counterparts.

• Sports cards (Multisport)

• Possibilities of development within the role and company’s structure

• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Extensive support of work life balance (flexible working solutions, short Fridays option, heal