Senior Manager Global Regulatory Affairs CMC

Posté 17 oct. 2022

Guidonia Montecelio, Rome - Italy

Demander un identifiant 257157


A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


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


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. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!