Regulatory Lead, Chemistry, Manufacturing and Controls Regulatory Affairs International Liaison
About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team, or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About this Job:
As a Regulatory Lead, Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs (RA) International Liaison, you will be responsible for reporting to the CMC Regulatory Affairs Modality Head or Global Head, you will influence and manage the global Regulatory CMC strategy for the International and Greater China markets, including MEAR, LATAM, APAC, and Mainland China. You will lead or support teams in executing this strategy, ensuring the company's interests are represented in key policy decisions and regulatory submissions.
Additionally, you will engage with internal and external stakeholders to address CMC regulatory issues, define regional strategies, and contribute to business growth. You will also represent the company in industry associations and forums, staying informed on regulatory trends and policies.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Activities for this role:
- Manages the holistic Regulatory CMC strategy for international markets, ensuring alignment with the company's global objectives.
- Collaborates with cross-functional teams, including Technology & Manufacturing, Quality Assurance, and Commercial colleagues, to execute regulatory strategies.
- Leads a team of CMC RA professionals, providing guidance and oversight on regional and country-specific regulatory issues.
- Assures that CMC regulatory strategies are effectively communicated and prioritized across international markets, particularly Greater China, MEAR, LATAM, and APAC.
- Represent the company's CMC Regulatory Affairs in industry associations and external forums, influencing policy and regulatory decisions.
- Develops and embeds regional regulatory expertise within the team, ensuring the organization's compliance and successful market entry.
Essential Knowledge & Experience:
- Experience in managing and executing global Regulatory CMC strategies across diverse international markets.
- Proven proficiency in collaborating with cross-functional teams to develop and implement regulatory strategies.
- Experience in leading and mentoring a team of regulatory professionals, driving performance and regulatory compliance.
- Proficiency in navigating complex regulatory environments, particularly in Greater China, MEAR, LATAM, and APAC regions.
- Experience in representing an organization in external industry forums, with a strong ability to influence regulatory policy.
- Must be capable of understanding and applying regulatory trends and guidelines to ensure successful product development and lifecycle management.
- Fluent in written and spoken business English.
Education/Qualifications:
- Bachelor’s degree/Master’s degree or equivalent.
Additional Information:
- 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 UK and 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.
