Associate Director, SDE Submission Technical Support

GSK is seeking an experienced leader to oversee theSubmission Delivery Excellence Submission Technical Support Team a global matrixed function supporting the entirety of the GRA CMC organization (500 staff) and other customer groups as this strategic role you will drive harmonization business change and ensure the on-time quality delivery of CMC submission components for development and lifecycle products.

Key Responsibilities:

• Lead and motivate a global team of staff across multiple locations (PO CA IN) ensuring alignment with GRA standards.
• Guide Regulatory Matrix Teams on creating CMC submission content for complex product applications supporting global R&D goals.
• Oversee Reg Vault activities related to Core Content Plans and Active Dossiers to ensure accuracy and global medicine supply continuity.
• Collaborate with stakeholders across GRO CMC and GRS to identify process efficiencies and refine workflows.
• Ensure quality delivery of high-volume CMC submission technical support requests across GSKs product portfolio worldwide.
• Drive process evaluation automation opportunities and implementation teams to meet internal and external requirements.
• Monitor and respond to key quality and performance indicators to ensure submission production efficiency.
• Develop and implement training plans to enhance staff expertise and ensure compliance with GRA standards.
• Establish networks and maintain strong relationships across GRA customer groups and leadership teams.
• Proactively identify and mitigate risks associated with regulatory deliverables to ensure compliance and market supply continuity.

Why You

Basic Qualifications:
We are looking for professionals with the following skills and experience:

• Bachelors Degree in Life Science or a technical field.
• Extensive knowledge of drug development manufacturing and supply processes.
• Extensive knowledge about Veeva Vault processes.
• Deep understanding of worldwide regulatory requirements particularly CMC processes.
• Proven experience managing multiple projects and teams.
• Line management experience with the ability to motivate and develop staff.

Preferred Qualifications:
If you have the following characteristics it would be a plus:

• Advanced degree in Chemistry Pharmacy or a closely related science field.
• Demonstrated growth in global regulatory affairs and awareness of evolving trends and policies.
• Strong project management and prioritization skills within complex IT system landscapes in regulated environments.
• Excellent communication negotiation and collaboration skills across cross-functional teams.
• Ability to implement new processes manage quality initiatives and deliver high-quality outputs under pressure.

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)
• Company Car
• Possibilities of development within the role and companys 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 health & well-being activities).
• Supportive community and integration events
• Modern office with creative rooms fresh fruits every day

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As an Inclusive employer we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at to discuss your needs.

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 were 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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

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