Regulatory Affairs Lead, Chemistry and Manufacturing
7 dagen geleden
Astellas is a progressive health partner delivering value and outcomes where needed. We pursue innovative science, focusing on areas of greatest potential and developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
The OpportunityAs the Regulatory Lead (RA), Chemistry, Manufacturing and Controls CMC, you will play a key role in a global leadership role. You will be responsible for multiple regulatory activities in collaboration with stakeholders, developing global CMC regulatory strategy, driving global CMC RA-related activities, and successfully executing regulatory strategies in collaboration with stakeholders.
Key Activities- 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.
- Collaborate with stakeholders to enhance submission quality and prepare summary tables from research and manufacturing reports.
- Ensure timely compilation and submission of global documents, reviewing for consistency and quality across regions, including eCTD Module 3 documents.
- Stay informed on corporate/global strategy and regulatory positions, contributing to strategic planning in the therapeutic area and CMC aspects with global stakeholders.
- 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 (including oral and parenteral dosage forms) is required.
- 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.
- Ability to work in cross-functional and international environment; detail and goal-oriented, quality conscientious, and customer-focused.
- Demonstrated track record for successful Health Authority interactions related to CMC submissions.
- Fluent in written and spoken business English.
- 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.
- Experience managing direct report is preferred.
- Additional experience beyond small molecules, such as biologics, vaccines, cell/gene therapy or medical devices might be a preference.
This is a permanent, full-time position. This position is based in the United Kingdom or the Netherlands. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in the Netherlands office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. 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.
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