Expert - Regulatory Labelling - Bengaluru, Karnataka
1 day ago
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.
Your Role:
As a Regulatory Labelling Specialist, you will be responsible for ensuring compliance with pharmaceutical regulations and laws. You will create and maintain global Reference Product Information and oversee the development and review of regulatory labels and product information.
Who You Are:
Minimum Requirements:
- Experience: 9-10 years in the pharmaceutical environment, including at least 5 years of labelling experience.
- Education: Medical, PharmD, or related discipline (minimum MSc or equivalent degree); higher degree preferred (e.g., PhD).
Maximum Requirements:
- Lead professional employees and/or lower-level staff; support/service/operations managers to solve problems of limited to medium complexity. Adapt operational plans and priorities to address resource and short-term operational needs.
- Execute assigned tasks independently while adhering to agreed timelines and proactively communicating any potential risks. Follow up with cross-functional contributors on their deliverables in a timely manner. Maintain appropriate risk assessment and mitigation in cooperation with line management.
- Utilize advanced skills with all standard MS Office and business applications (Word, Excel, PowerPoint, MS Project, Outlook, Skype, SharePoint). Possess contributor-level experience with RIMS and EDMS RA applications.
- Demonstrate solid experience in Regulatory Affairs, including regulatory dossiers and procedures on a global scale. Understand the structure and processes of Regulatory Agencies and possess in-depth knowledge of registration procedures and lifecycle management strategies.
- Understand how business operates and make informed decisions while maintaining a strategic perspective. Have a thorough knowledge of EU regulatory requirements and labelling processes.
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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