Job Description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role can be done in hybrid working model from the office in Warsaw.

Your role:

Are you a seasoned Regulatory Affairs professional with a strategic mindset and a passion for advancing clinical trials? We are seeking a highly experienced Regional Regulatory Affairs Manager to drive our CTA landscape, ensuring seamless regulatory execution, compliance and excellence. In this pivotal role, you will be the go-to expert on CT requirements, guiding and shaping our CTA regulatory strategies and applications across diverse geographies. Your deep expertise in CT regulatory frameworks and processes, combined with a solid cross-functional collaboration will be instrumental in driving successful trials roll-out in adherence with regulatory standards and with the R&D target plans. Monitor the pipeline and development programs and derive regulatory plans for the regions. Administrate local Health Authority (HA) requirements gathering and initiate communication of regulatory intelligence, including assessment of needs and documentation of insights.

You will also manage end-to-end Clinical Trials Applications, from strategy planning to submission, AtOs management, approval, and lifecycle management, through solid interactions with HAs. Serve as the regional expert on Clinical Trials Regulations and related guidelines. Drive in country/s clinical trials submission management from planning to finalizing local submissions in alignment with global objectives and requirements. Ensure clinical trial submission activities comply with applicable regulations, guidelines, and company policies. Drive cross-functional collaboration to align strategies and facilitate smooth CT submission. Provide expertise and guidance to regional teams on regulatory requirements, changes, and best practices. Monitor evolving regulatory landscape affecting clinical trials and advise internal teams accordingly, following the trends and competitors activities in the CT area. Provide training and mentorship if needed on CT requirements and regulatory best practices. Develop and maintain up-to-date knowledge resources and WoW related to clinical trial regulations. Provide an appropriate level of leadership guidance, support, coaching, and tools to relevant stakeholders. Oversee and coordinate projects for the region on a TA basis. Perform a range of routine or non-routine assignments to solve problems of low to moderate complexity that require working knowledge and experience in the own job discipline. Support in preparing and analyzing variances to accomplish financial objectives.

Who you are:

• 5 - 10 years of experience in regulatory affairs management, specifically with clinical trials submission and LifeCycle within the EU region, in non EU is a plus, demonstrating in-depth knowledge of EU Clinical Trials Regulation (EU CTR), GCP, and other relevant regulations.
  Know-how in regulatory requirements for complete lifecycle of a product, from initial development through preclinical and clinical trials, to post-marketing surveillance and product withdrawal if necessary in the country or region. Proven experience managing clinical trial submissions, interactions with regulatory authorities, and compliance activities. Knowledge of regulations governing the design, conduct, and reporting of clinical trials with ability to interpret complex regulatory information and provide strategic guidance.

• Ability to execute assigned task independently, strong project management skills & proactive communication approach, driving process excellence, mitigate business risks & ensure compliance as well as effectively design, prioritize, keep information confidential, escalate issues, manage time effectively, gain alignment and successfully execute processes.

• Gain visibility in duplicating or contradicting processes to eliminate or adapt them as needed to increase quality & speed execution.

• Ability to focus on implementing measurements and taking corrective actions on processes management. Ability to make process design decisions conditionally, with the understanding that they may or may not work out as you continue toward a final solution. Knowing when to change and when to stick with previous decisions.

• Ability to interact effectively with all levels of management, acquire know-how, emphasize team learning & plan apprenticeship with experienced colleagues.

• To create clear, easy-to-follow work schedules with specific requirements and deadlines to maintain high standards with optimal efficiency.

• Be comfortable, understand how to assess & evaluate the impact of change within a team/organization. Effectively prioritizes competing tasks in a fast-paced and dynamic environment.

• Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success. Know-how on project budget management. High proficiency in English.

YOUR MAIN BENEFITS:

• Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card
• Work-Life balance: Enjoy additional paid days off, flexible working hours.
• Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities
• Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.

Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!