United Kingdom Job Openings

Astellas Pharma Europe

Regulatory Lead, Chemistry, Manufacturing and Controls Regulatory Affairs International Liaison

Addlestone

FULL TIME

September 12, 2024

About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then 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.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
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:

Manage the holistic Regulatory CMC strategy for international markets, ensuring alignment with the company's global objectives.
Collaborate with cross-functional teams, including Technology & Manufacturing, Quality Assurance, and Commercial colleagues, to execute regulatory strategies.
Lead a team of CMC RA professionals, providing guidance and oversight on regional and country-specific regulatory issues.
Assure that CMC regulatory strategies are effectively communicated and prioritized across international markets, particularly in Greater China, MEAR, LATAM, and APAC.
Represent the company's CMC Regulatory Affairs in industry associations and external forums, influencing policy and regulatory decisions.
Develop 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.
Must be able to lead and mentor 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 or equivalent.
Master’s degree or equivalent. (Preferred but not essential)

Additional Information:

This is a permanent full-time position.
This position is based in the United Kingdom.
This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in the UK 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.
Job Types: Full-time, Permanent
Work Location: Hybrid remote in Addlestone, KT15 2NX

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