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- Aufgaben: Lead global regulatory CMC strategy from clinical development to market authorization.
- Arbeitgeber: Join a leading biotech company revolutionizing patient care with innovative mRNA treatments.
- Mitarbeitervorteile: Enjoy a full-time role with opportunities for professional growth in a dynamic industry.
- Warum dieser Job: Be part of a mission-driven team transforming lives through cutting-edge science and technology.
- Gewünschte Qualifikationen: Requires a scientific degree and strong experience in global CMC regulatory strategy.
- Andere Informationen: Supervise vendors and optimize regulatory processes in a collaborative environment.
Das voraussichtliche Gehalt liegt zwischen 90000 - 126000 € pro Jahr.
Watton Hall are partnered with a leading biotech company focused on developing innovative mRNA treatments aimed at transforming patient care in various therapeutic areas. Their commitment to advancing science and improving lives drives their mission and they are seeking a Senior Director, Global Regulatory Affairs CMC to lead programs through development up to commercialisation.
Key Responsibilities
- Acting as Global Regulatory CMC Lead to define and execute the CMC regulatory strategy from clinical development up to market authorisation.
- Plan, prepare, and conduct interactions with regulatory agencies in the field of CMC.
- Establish, modify, and continuously optimise regulatory CMC processes and interfaces (internal and external).
- Supervision of vendors in the regulatory affairs department and preparation of regulatory CMC dossiers.
Candidate Profile
- Scientific degree or any related discipline.
- Strong professional working experience in global CMC regulatory strategy leading activities.
- Knowledge of the interdisciplinary functions involved in CMC drug development and the application of clinical research to drug development and Medical Devices.
Seniority level
Director
Employment type
Full-time
Job function
Management, Manufacturing, and Strategy/Planning
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Global Regulatory Affairs CMC Lead Arbeitgeber: Watton Hall
Kontaktperson:
Watton Hall HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Global Regulatory Affairs CMC Lead
✨Tip Number 1
Make sure to stay updated on the latest trends and regulations in CMC. This knowledge will not only help you during interviews but also demonstrate your commitment to the field.
✨Tip Number 2
Network with professionals in the biotech and pharmaceutical industries. Attend relevant conferences or webinars to connect with others who may provide insights or referrals for the position.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led CMC regulatory strategies in the past. Highlighting your experience will show that you're the right fit for this senior role.
✨Tip Number 4
Familiarize yourself with the company's mission and recent developments in mRNA treatments. Tailoring your conversation around their goals can set you apart as a candidate who truly understands their vision.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Global Regulatory Affairs CMC Lead
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly understand the responsibilities of the Global Regulatory Affairs CMC Lead position. Highlight your relevant experience in leading CMC regulatory strategies and interactions with regulatory agencies.
Tailor Your CV: Customize your CV to emphasize your scientific background and professional experience in global CMC regulatory strategy. Include specific examples of your leadership in regulatory affairs and any successful projects you've managed.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for biotechnology and your commitment to advancing patient care. Discuss how your skills align with the company's mission and how you can contribute to their innovative mRNA treatments.
Highlight Interdisciplinary Knowledge: In your application, make sure to mention your knowledge of interdisciplinary functions involved in CMC drug development. This will demonstrate your comprehensive understanding of the regulatory landscape and its impact on drug commercialization.
Wie du dich auf ein Vorstellungsgespräch bei Watton Hall vorbereitest
✨Understand the CMC Landscape
Make sure you have a solid grasp of the current trends and challenges in CMC regulatory affairs. Familiarize yourself with recent developments in mRNA treatments and how they impact regulatory strategies.
✨Showcase Your Leadership Experience
Be prepared to discuss your previous experiences leading regulatory teams and projects. Highlight specific examples where you successfully navigated complex regulatory environments and achieved positive outcomes.
✨Prepare for Regulatory Agency Interactions
Think about how you would approach interactions with regulatory agencies. Be ready to discuss your strategies for effective communication and collaboration, as well as any past experiences that demonstrate your skills in this area.
✨Demonstrate Process Optimization Skills
Discuss your experience in establishing and optimizing regulatory CMC processes. Provide examples of how you've improved efficiency and effectiveness in previous roles, and be ready to suggest ideas for continuous improvement.
