Opis stanowiska podany przez pracodawcę:

Responsibilities:

• Lead and align regional regulatory affairs teams (EMEA, LATAM, APAC) to implement digital labeling initiatives in accordance with global strategy
• Act as a regulatory subject matter expert (SME) for digital labeling and ePI, guiding both global and local regulatory teams
• Provide end-to-end oversight of cross-regional labeling projects, ensuring compliance with local and regional regulatory requirements
• Support the development and coordination of local and regional process documents and regulatory position papers
• Collaborate closely with Digital Innovation & Technology (DI&T) teams to ensure regulatory input is integrated into labeling systems and processes
• Manage multiple projects simultaneously, track milestones, and address roadblocks in collaboration with cross-functional teams
• Represent Regulatory Affairs in cross-functional forums and discussions related to digital labeling technologies and strategy
• Contribute to shaping the long-term regulatory approach to ePI in line with global regulatory and corporate goals
• Provide training and mentorship to regional teams on digital labeling best practices and evolving regulations
• Support external shaping by preparing for regulatory agency interactions and engagement with industry groups.

Requirements:

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field; Master’s degree preferred
• Minimum 5-7 years of experience in Regulatory Affairs, preferably with a focus on labeling or digital initiatives
• Proven experience leading cross-regional or cross-functional regulatory projects
• Strong understanding of global and regional regulatory labeling requirements, including digital trends such as ePI
• Familiarity with digital labeling platforms or tools (e.g., Veeva, structured product labeling systems) is a plus
• Excellent communication and interpersonal skills, with the ability to influence and align diverse stakeholders
• Demonstrated project management skills and ability to deliver on complex, multi-region initiatives
• High adaptability and problem-solving mindset in a fast-paced, evolving environment

Offer:

• Opportunity to work on the forefront of digital transformation in regulatory affairs
• Dynamic and collaborative work environment within a global pharmaceutical setting
• Option for 100% remote work within Poland
• Work primarily in English with international teams
• Competitive salary and benefits package
• Opportunity to shape global labeling strategy and contribute to meaningful innovation in healthcare communication 

Permanent job offer. 

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