Senior Manager Global Regulatory Affairs CMC
2 mesi fa
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:
You are responsible in this role to lead and drive regulatory Chemistry, Manufacturing and Control (CMC) activities. You develop and are accountable for the global regulatory CMC and CMC dossier strategy. Furthermore, in being responsible for leading the content of the CMC dossier you act as liaison between Global Regulatory Affairs and CMC technical functions for marketed Biotech products. This encompasses the accountability for strategic planning, authoring, review and approval of all relevant regulatory CMC documents (e.g. M3, M2.3, Answer to Objections). You are accountable for evaluation, interpretation and translation of the country regulatory requirements into CMC/technical requirements and to provide them proactively as prospective advice to the CMC functions. Furthermore, you are accountable for CMC topics in the context of Health Authority interactions/meetings. In addition, you contribute to risk and gap assessments. You are a permanent member in the Global Regulatory Strategy team, the CMC project team and other international and interdisciplinary working groups.
Who you are:
University degree in pharmacy or chemistry or life science, Ph.D. beneficial
Minimum of 5 years of pharmaceutical industry or health authority experience, with at least 3 years of global CMC regulatory experience
Excellent communication skills including interaction with all levels of the organization
Broad knowledge of regulatory CMC requirements (EU, US, ICH and other relevant guidelines) as well as US Pharmacopoeias and GMP regulations
Experience in Health Authority interactions
Excellent written and spoken communication skills in English.
Falling under law L.68/99
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team
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