About This Role
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.
Responsibilities:
- Build and lead own team of professional staff to meet current and future regulatory objectives in alignment with local, regional and global Regulatory and Commercial objectives.
- Ensures high level of alignment with GM on a continuous dynamic basis, while playing a key role in his/her leadership team.
- Identifies and resolve technical, operational and organizational problem of medium to serious complexity.
- Filters, prioritizes, analyzes and validates dynamic material from diverse range of external and internal sources to respond to and mitigate operational challenges.
- Applies understanding of how different areas jointly contribute to achieving objectives within the sub-function.
- Develops strategy and define principles and guidelines for the area of responsibility.
- Ensures cluster/country alignment with global priorities.
- Develops and manages the departmental budget.
- Keeps abreast of dynamic regulatory, compliance and statutory requirements in the global, regional and local environment in order to ensure organizational compliance.
- Develops and enhances relationships with regulatory and industry bodies in order to represent the interests of the organization, gains relevant information, shapes changes and influences legislation.
- Communicates all quality complaints received within 24 to QA Department.
- Communicates all AEs received within 24 h to Patient Safety Department.
Participate to all GDP trainings according to defined training matrix
- Impacts the level of service and teams' performance to meet quality, volume and timeliness of objectives which affects the performance of the entire cluster.
- Contributes with value-added perspectives and advisory services that are important to decision making.
- Has responsibility for planning of resources, budgets and policies.
- Development of regulatory strategy for the cluster/country as applicable.
- Lead the Regional and assist Global Regulatory team in analyzing country/region product data, Regulatory legislation and providing country/region
People Management:* Manages a team that consists largely of professionals and is accountable for the performance and results of the team.
- Responsible for day-to-day management, setting objectives, coaching and developing employees, performance appraisal, determination of reward outcomes.
- Contributes to the definition of roles and responsibilities.
- Contributes to the business and financial planning process.
Cooperation:
Internally: with Commercial team, SNO, Quality, PV, Sites, GRA Externally: with SFDA, GHC, Agents, Vendors, RPCC, Others as applicable ie SAIP, SNIH
Education:
Typical requires a pharmacy or chemical engineering or chemistry or biology unless any legal obligation graduate degree that provides knowledge of theories, principles and concept within a relevant discipline.
Work Experience:
- Requires substantial professional experience (approximately 8-10 Years as a guide) including managerial responsibility.
- Require depth and/or breadth of expertise in own specialized discipline or field combined with knowledge of the market and competitors.
- Exposure to manufacturing, distribution, quality, pharmacovigilance and compliance is an advantage.
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!
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