Associate or (Senior) Manager Regulatory Affairs and/or Quality Assurance

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 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.

Amongst the main responsibilities for this role are the following:

You are part of a team of Regulatory Affairs and Quality Assurance Managers and will report to the Associate Director RA & QA (affiliate RA & QA Lead).

As RA & QA contributor you will be responsible for the local Regulatory Affairs and/or Quality Assurance activities. (Senior) Manager position may take on more advanced and independent responsibilities

• RA: timely prepare, submit and conduct appropriate follow-up of new Marketing Authorization and Life Cycle Management applications to the national competent authorities.
• RA: ensure high quality labelling translation and compliant printed packaging materials of marketed products.
• RA: Review of (non)Promotional materials to ensure compliance with approved Product Information and with the Code for Pharmaceutical Advertising (CGR code)
• RA/QA: Collect relevant publicly available regulatory information (regulatory intelligence) and stay updated on relevant EU and local regulations and guidelines
• RA/QA: Provide regulatory guidance to multidisciplinary teams to ensure that development or maintenance activities (in the context of approved business activities) are performed in time and in compliance with applicable regulatory demands (legislation and guidelines) throughout the product’s life cycle.
• QA: Perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorization Holder
• QA: Maintain the Quality Management System; implementation and continual improvement of QM systems, processes, i.e.: handling of deviations, complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues.
• QA: Prepare for QA internal audits and GDP/GMP Inspections by Competent Authorities, and assist the RA &QA Lead & Responsible Person during these inspections.
• QA: (Depending on the seniority) Act as a deputy Responsible Person (RP) as defined in EU GDP Guideline 2013/C 343/01 (if applicable)

Essential Knowledge & Experience:

• MS Degree in Pharmacy or other Life Science or equivalent by experience.
• For the (Sr) Associate level, a minimum of 1-2 years experience in the pharmaceutical Industry is preferable, in a regulatory, quality, medical or laboratory position.
• For the managers level, a minimum of 3 years experience in a Registration Department/ Quality department, dealing with most aspects of registration/Quality, with sufficient working knowledge of the subject area to require minimal supervision from the Manager. Knowledge of Regulatory landscape and procedures within the country/region.
• For the Sr Managers level, a minimum of 4 years experience in Registration Departments/Quality department, dealing with most aspects of registration/Quality, with sufficient working knowledge of the subject area to require minimal supervision from the Manager. Knowledge of Regulatory landscape and procedures within the country/region.
• Proficiency in Dutch and English language
• Proficiency in PC use with regard to word-processing, spreadsheets, database application, and internet.
• Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills. The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work. Must be able to work both alone and as part of a team, and have the ability to concentrate on large volumes of written/paper based work in an office environment.
• A sound appreciation of the interactions and relationships of the department with other internal departments is expected.
• Dutch (mandatory) and fluent English language

Additional information:

• Currently this position has the flexibility to work from home and in the office.
• Full time.

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.