Algemene informatie

Vacatureadvertentie

Specialist, Regulatory Affairs Chemistry, Manufacturing and Controls

Locatie

Nederland

Functie/Business Area

Regulatory Affairs

Afdeling

RA-CMC EMEA I

Werkcategorie

Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Specialist, Regulatory Affairs Chemistry, Manufacturing and Controls

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 Senior Manager in Regulatory Affairs for Chemistry, Manufacturing, and Controls, you will be responsible for developing and executing regulatory strategies for the chemistry, manufacturing, and controls aspects of drug development. This includes preparing, reviewing, and submitting documentation such as quality modules, investigational new drug applications, and other regulatory filings to global health authorities like the European Medicines Agency, the United States Food and Drug Administration, and the Pharmaceuticals and Medical Devices Agency in Japan.
You will act as the lead or subject matter expert for regulatory matters related to chemistry, manufacturing, and controls, collaborating closely with cross-functional teams to ensure compliance with global regulatory standards. Additionally, you will provide guidance on issues related to chemistry, manufacturing, and controls, support strategic planning, and oversee the preparation of global registration packages to facilitate successful product approvals.

Key Activities for this role:
Develop and execute CMC regulatory strategies. You will be formulating and implementing strategies for the chemistry, manufacturing, and control aspects of drug development to ensure compliance and successful product approval.
Prepare and review regulatory documentation. You will be creating and overseeing the submission of regulatory documents, including quality modules and investigational new drug applications, for global health authorities.
Ensure compliance with global regulatory standards. You will be acting as a subject matter expert to interpret and apply international regulations and guidelines, ensuring that all CMC submissions meet the requirements of agencies like the FDA, EMA, and PMDA.
Collaborate with cross-functional teams. You will be working closely with departments such as Pharmaceutical Technology, Quality Assurance, and other regulatory affairs teams to align on regulatory strategies and document preparation.
Interact with health authorities. You will be engaging in communication and meetings with global health authorities to discuss regulatory submissions, respond to inquiries, and ensure the acceptance and approval of products.

Essential Knowledge & Experience:
Extensive Experience in CMC Regulatory Affairs in managing regulatory affairs specifically related to chemistry, manufacturing, and controls, including strategy development and execution for new molecular and biological entities.
In-depth Knowledge of Global Regulatory Requirements. Thorough understanding of international regulatory standards and guidelines from agencies such as the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA).
Proven Experience in Preparing Regulatory Submissions such as creating, reviewing, and submitting complex regulatory documents, including quality modules and investigational new drug applications, to meet global regulatory requirements.
Strong knowledge of drug substance and drug product development processes, including analytical characterization, process development, and scale-up across various dosage forms.
Demonstrated success in engaging with global health authorities, including providing responses to inquiries, participating in meetings, and negotiating regulatory outcomes.
Fluent in written and spoken business English.

Education/Qualifications:
Bachelor’s degree or equivalent.

Additional Information:
This is a permanent, full-time position.
This position is based in 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. Candidate 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.