Vacature Associate Regulatory Affairs Director, Chemistry Manufacturing and Controls

Associate Regulatory Affairs Director, Chemistry Manufacturing and Controls

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.

About this role

As an Associate CMC Regulatory Affairs Director, you'll lead global Regulatory Affairs for Chemistry, Manufacturing, and Controls (CMC) in regulatory documents and submissions. Your role involves overseeing multiple regulatory tasks, collaborating with various stakeholders (such as other RA functions, Pharmaceutical Technology, Quality Assurance, and Business Partners). You'll develop global CMC regulatory strategy, drive related activities globally, and execute regulatory plans in collaboration with stakeholders. Additionally, you'll handle crucial interactions within and outside Astellas Regulatory Affairs concerning complex CMC issues in partnership with local and global stakeholders.

At Astellas we recognise that our employees enjoy having balance between their professional and home lives.  We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

In this role you will:

• Lead highly complex CMC regulatory projects, offering expertise and strategic recommendations within global project teams, ensuring alignment with applicable regulations (EMA/FDA/ICH), and collaborating with stakeholders for risk assessment.
• Manage preparation and review of intricate global registration packages, ensuring quality data presentation aligned with regulatory standards. Defines and implements regulatory strategies for global registrations, variations, and responses to health authorities.
• Oversee global submissions' compliance with schedules and SOPs, reviews submissions for consistency and quality, including input on eCTD Module 3 documents, and ensures effective communication across regions.
• Actively seek corporate/global strategy insights, impacting regulatory positions, and participates in strategic planning for therapeutic areas and global stakeholders in CMC aspects.
• Provide regulatory guidance on compendial issues, national monographs, and preparation of compendial monographs, contributing to regulatory compliance.

Essential Knowledge & Experience:

• Extensive industry experience, including also Regulatory Affairs or roles involving CMC regulatory responsibilities.
• Extensive experience in global CMC regulatory aspects across various dosage forms, dealing with technical complexities and undefined frameworks. Proficiency in process development, analytical characterization, and regulatory registration of drug substances/products (oral and parenteral forms).
• Advanced communication skills (written and oral), adept at proactive and reactive collaboration in a dynamic, fast-paced setting.
• Comprehensive knowledge and experience with EU, US, and/or Japan regulations, guidelines, and processes for New Chemical Entities (NCEs), New Biological Entities (NBEs), and product lifecycle maintenance.
• Ability to thrive in cross-functional and international environments.
• Fluent in English,

Preferred Experience:

• Additional experience beyond small molecules, such as biologics, vaccines, cell/gene therapy or medical devices might be a preference.

Required qualification:

• BS in Chemistry or equivalent degree.

Additional information:

• Type of role permanent
• Location Netherlands or United Kingdom
• Hybrid work This position follows our hybrid working model. Role requires a blend of home and minimum 1 day per week in our Netherlands/UK office.  Flexibility may be required in line with business need. 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.

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met WilsonHCG EMEA Ltd. via stmglobal@wilsonhcg.com of onbekend. Of bezoek hun website https://www.wilsonhcg.com/emea?redirect=1.