City :

Category : Other

Industry : Healthcare

Employer : GSK

Senior Manager, Development and Regulatory Operations

This role leads a group of Business System Owners (BSOs) at GlaxoSmithKline (GSK) and is responsible for overseeing the strategic management and continuous improvement of key regulatory business systems. Additionally, this role serves as the BSO for the Content Generation Service (CGS) app which is a tool leveraging AI and built on the Mendix platform that creates draft regulatory documents. This app is a key part of GSK’s hyper-acceleration strategy, which aims to dramatically speed the process of getting new products into the hand of patients that need them.

BSOs ensure that all regulatory systems are effectively supporting global regulatory operations, compliance, and business objectives. The Senior Manager leads a team of BSOs, fostering collaboration, driving innovation, and ensuring alignment with GSK’s regulatory strategy. By optimizing the performance and integration of regulatory systems, the Senior Manager enhances operational efficiency, data integrity, and regulatory reporting, ultimately supporting GSK’s mission to deliver high-quality products to patients worldwide.

Locations: Poland (Poznan, Warsaw), Mexico City,  Milverton (Canda)

Key Responsibilities:

• Strategic Leadership:

Provide strategic direction and leadership to the team of Business System Owners, ensuring alignment with GSK’s global regulatory operations and business objectives

• System Management:

Oversee the management, maintenance, and optimization of key regulatory business systems to ensure they meet the needs of regulatory operations and compliance requirements

• Cross-Functional Collaboration:

Collaborate with Regulatory Affairs, IT, Quality, and other cross-functional teams to ensure regulatory systems support end-to-end regulatory processes and business needs

• Innovation and Improvement:

Drive continuous improvement initiatives for regulatory systems, leveraging new technologies and best practices to enhance system performance, user experience, and data integrity

• Compliance and Risk Management:

Ensure regulatory systems comply with global regulatory requirements and internal standards, and proactively identify and mitigate risks associated with system usage and data management

• Project Oversight:

Oversee the planning, execution, and delivery of projects related to regulatory system enhancements, upgrades, and new implementations, ensuring they are completed on time and within budget

• Resource Management:

Manage resources effectively, including budget, personnel, and technology investments, to support the successful operation and enhancement of regulatory systems

• Training and Development:

Develop and implement training programs for Business System Owners and other stakeholders to ensure they are proficient in using regulatory systems and aware of best practices

• Performance Monitoring:

Monitor and evaluate the performance of regulatory systems, using key performance indicators (KPIs) and metrics to ensure they meet business needs and regulatory requirements.

• Stakeholder Communication:

Serve as the key point of contact for regulatory system-related matters, providing regular updates and communications to senior management, stakeholders, and regulatory authorities as needed.

Why you? 

Basic Qualifications:

• A Bachelor’s degree in a relevant field such as Life Sciences, Pharmacy, Regulatory Affairs, Information Technology, or a related discipline is required
• Relevant professional certifications such as Regulatory Affairs Certification (RAC), Project Management Professional (PMP), or certifications in IT systems management or data governance

• Experience delivering business operational support to critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labeling Management Systems)
• Lead and participated in Business Change Teams delivering IT solutions for the business
• Extensive experience of working within a regulated project delivery environment
• Ability to communicate and provide assistance and support on both sides of the Business-IT interface
• Proven ability to interact effectively with senior managers within the organization
• Experience managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development
• Experience in Business Analysis and Business Process Design
• Fluent and able communicator in English and local language
• Strong communication and influencing skills
• Ability to self-manage the work and prioritize effectively
• Service orientation, customer-focused
• Good team worker, but with confidence to lead when appropriate
• Good understanding of IT lifecycle, processes and quality management
• Software and System Experience (one of more of the following):

Parexel Insight Manager – RIM and Cognos Reporting

Documentum D2 – Labeling System

CSC Regulatory Submission Suite (eCTDXpress, Publisher, Toolbox, Viewer)

Global Submit Validate – Lorenz eValidator

Axway eSubmission Gateway – FDA Web Trader, EMA Gateway CESP

Veeva Regulatory Vault

SharePoint

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)
• Company Car
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards
• 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, health & well-being activities)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits every day

Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career.
GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (pl.recruitment-adjustments@gsk.com) to further discuss this today.

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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