Associate Chemistry Manufacturing Controls Regulatory Affairs Director
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.
This opportunity is located in the Netherlands for Associate Chemistry Manufacturing Controls Regulatory Affairs Director
About this job
In this pivotal role at Astellas, you become a crucial part of the global leadership within the Regulatory Affairs department. Your focus is specifically on the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory documents and submissions.
You'll embark on a collaborative journey with diverse stakeholders, joining forces with other Regulatory Affairs functions, the Pharmaceutical Technology team, Quality Assurance experts, and valued Business Partners.
Your mission is to craft a dynamic global CMC regulatory strategy, actively engage in vibrant global CMC RA activities, execute regulatory strategies with finesse, and deftly manage intricate interactions surrounding complex CMC matters—both within and beyond the realm of Astellas Regulatory Affairs.
Get ready to infuse your expertise with enthusiasm as you make a meaningful impact in this vibrant and globally influential role!
In this job, you will
- Serve as a CMC regulatory lead for highly complex projects/products or engage in overarching activities.
- Potentially manage a small team or act as a mentor for individuals within the organization.
- Act as a CMC regulatory expert within global project teams/task forces, ensuring accountability for recommending global CMC regulatory strategy.
- Contribute to global project teams/task forces requiring expert interpretation of applicable EMA/FDA/ICH/Global regulations, ensuring CMC compliance.
- Provide CMC regulatory expertise for New Product Planning and Licensing due diligence activities.
Essential Knowledge & Experience
- Previous industry experience, directly in Regulatory Affairs or CMC regulatory roles.
- Knowledge of EU, US, or Japan regulations, guidelines, and regulatory processes.
- Experience in managing direct reports, additional experience beyond small molecules.
- Demonstrated track record for successful Health Authority interactions related to CMC submissions.
Preferred Knowledge & Experience
- Experience with global regulatory aspects of CMC across multiple dosage forms.
- Advanced interpersonal and collaborative skills, ability to work in a dynamic, fast-paced environment.
- Ability to manage complex projects by exercising independent decision making and analytical thinking skills.
- Advanced interpersonal written and oral communication skills, as well as advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment.
- Master of Science or Doctor of Philosophy in Chemistry/Biochemistry or equivalent.
- Permanent position.
- This position is 100% home / remote based.
- Candidates from the United Kingdom are welcome to apply.
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.