Site Name: Poznan Grunwaldzka, Warsaw Posted Date: Feb 19 2025 CMC Renewals Regulatory Manager with digital experience At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life. The CMC Renewals Team in Global Regulatory Affairs supports GSK's portfolio by ensuring the quality, safety, and efficacy of our products. As a Regulatory Manager, you will make a positive impact by delivering CMC submissions and ensuring the supply of life-saving medicines. You will oversee a team, manage their professional growth, and resolve resource or quality issues. Collaboration with internal and external stakeholders is essential to meet our objectives. Additionally, you will enhance your team's digital capabilities by implementing tools and technologies to streamline processes and improve efficiency. Your leadership will drive the digital transformation of our regulatory operations, contributing to GSK's success. Fixed-term contract: until Aug 31, 2026 Key Responsibilities Lead team development: Manage and develop a team of direct reports to foster a productive and motivating work environment. Plan and deliver submissions: Ensure timely and high-quality delivery of Pharma and Vaccines CMC submissions. Maintain submission standards: Act as a quality control point, identifying and mitigating risks to ensure high standards and timely project completion. Resolve issues: Address and escalate resource or quality issues as needed to maintain project timelines. Drive process improvement: Continuously improve processes within your area of influence. Enhance digital capabilities: Implement digital tools and technologies to streamline regulatory processes and improve efficiency. Build stakeholder relationships: Establish and maintain strong relationships with internal and external stakeholders. Collaborate for standardization: Work with peers and managers to drive standardization across the business. Monitor team performance: Track, analyse, and report on team performance against departmental KPIs. Qualifications & Skills Proactive approach with the ability to drive the team through change and enhance digital capabilities. Sound understanding of regulatory affairs and pharmaceutical industry, especially in CMC Regulatory Affairs. Capability to build, motivate, and maintain a team. Bachelor’s degree (or higher) in a scientific or technical field. Fluent in English and Polish (both spoken and written). Strong interpersonal and communication skills. Ability to perform multiple tasks and set the right priorities to deliver objectives on time. Adaptability to changing circumstances through priorities reassessment and a disciplined, logical work style. Preferred Qualifications Leadership experience, with the ability to manage, motivate, and guide teams through change. Change management and strong learning agility. Negotiation and problem-solving skills. Practical knowledge of risk management. Project Management experience would be an asset. We offer Career at one of the leading global healthcare companies 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 (mentoring, online training’ platforms: 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 everyday Free car and bike parking, locker rooms and showers 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. #LI-GSK #LI-HYBRID #LI-DEI 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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