Global Regulatory Affair Cmc Intelligence
vor 1 Woche
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.
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:
The Associate Director of Global Regulatory Affairs for CMC Regulatory Intelligence is responsible for enabling colleagues working with products either in development or marketed (e.g., chemicals, biologicals, drug-device combinations) to acquire additional CMC Regulatory knowledge and expertise that can be suitably applied to meet patients' needs and address Health Authority expectations.
The successful incumbent will also contribute in sharing internally a comprehensive understanding of the regulated bio-pharmaceutical environment as well as maintaining and updating it, as appropriate.
As the Associate Director of GRA CMC Regulatory Intelligence, you will oversee and shape future regulations, provide sound scientific and regulatory information from the existing WW CMC regulatory environment, and contribute to building a robust regulatory CMC knowledge foundation by also consulting and updating the internal CMC Regulatory Intelligence databases.
You will drive and facilitate CMC Regulatory knowledge adoption and understanding of evolving CMC Regulatory requirements in close collaboration with CMC-related departments and technical functions.
You will lead the process for commenting, interpreting, and performing risk analysis of CMC guidelines in collaboration with stakeholders from Regulatory Affairs (Global and Local) and other functions.
You will provide comprehensive advice to increase the probability of successful CMC dossier submission and facilitating swift alignment on the decision-making process for CMC strategy.
In addition, you will proactively develop strategic internal and external interactions and collaborative partnerships with Health Authorities and trade associations.
Internally you will lead specific Regulatory CMC intelligence committees and networks. Externally, you will represent the company in industry associations, expert working groups, public conferences, workshops, and congresses. You will ensure that consistent communication both internally and externally is always in place.Occasionally, you are expected to provide executive abstracts of complex CMC Regulatory and technical matters to enable the Senior Management making prompt decisions, as appropriate.
Who you are:
- You hold a degree in Life Sciences or a related discipline (minimum MSc or equivalent. Postgraduate degree highly preferred).
- You have a minimum of 7 years of experience with strategic and businesscritical responsibilities in CMC Regulatory Affairs and/or CMC Regulatory Intelligence in the industry or as a Quality assessor/CMC reviewer within a governmental institution.
- You have indepth knowledge of global pharmaceutical legislation and CMC Regulatory requirements.
- You are aware of the Regulatory Affairs contribution to the biopharma business.
- You have experience in preparing, reviewing, and strategizing CMC Regulatory documentation during clinical development and/or lifecycle management activities.
- You have handson experience in one of the following areas (biotech molecules preferred): manufacturing process development, transfers, validation, analytical development and quality management.
- You are proficient in English.
- You have the ability to: think strategically, be proactive, propose a potential solution (for team evaluation) when you encounter a new issue, turn a challenge into an opportunity and constructively collaborate across functions and departments.
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 deve-
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