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Regulatory Affairs Lead
1 maand geleden
Astellas is a progressive health partner that delivers value and outcomes where needed. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.
The OpportunityWe are seeking a highly skilled Regulatory Affairs Lead to play a key role in a global leadership role. As the CMC Regulatory Lead, you will be responsible for multiple regulatory activities in collaboration with stakeholders, including developing global CMC regulatory strategy, driving global CMC RA-related activities, and successfully executing regulatory strategies.
Key Responsibilities- Serve as the CMC regulatory lead or Deputy for complex projects/products and participate in related activities.
- Manage a small team or mentor one or more individuals.
- Act as a CMC regulatory expert for global project teams, recommending CMC regulatory strategies and ensuring alignment with global and local stakeholders.
- Oversee the preparation and review of complex global registration packages, ensuring effective data presentation and compliance with regulatory requirements.
- Ensure timely compilation and submission of global documents, reviewing for consistency and quality across regions.
- Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
- Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products.
- Ability to manage complex projects by exercising independent decision making and analytical thinking skills.
- Knowledge/experience of EU, US and/or Japan regulations, guidelines, and regulatory processes for NCEs, NBEs and product life cycle maintenance.
- Combination product experience (US, EU, JP).
- M.S. or Ph.D in Chemistry/Biochemistry/Engineering, PharmD or equivalent degree and relevant experience in CMC regulatory or role with CMC regulatory submission responsibilities.
Astellas offers a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
