Fonolive Marketplace App on Google PlaystoreFonolive Marketplace App on App Store - Apple iOS
  • jobs
  • 1 month ago

jobs description

General Information

Job Advert Title
Regulatory Operations Manager


Function/Business Area
Regulatory Affairs

Publishing and Submissions

Employment Class


Regulatory Operations Manager
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 in sights 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.

The Opportunity:

As the Regulatory Operations Manager, you will be a member of the Publishing & Submission team. Your responsibilities include managing the planning, preparation, submission, and tracking of correspondence, applications, and other structured data to regulatory agencies; identifying and ensuring adherence to relevant submission standards; and interacting with key personnel within the global Regulatory Affairs organization to resolve procedural and operational complexities. The position also involves execution-focused interactions with regional health authorities and other Astellas functions such as Pharmacovigilance, Data Science, and other areas within Medical & Development.

Hybrid Working:

At Astellas we recognize 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.

Key Activities for this role:
• Manage the planning, preparation, delivery, and archiving of published submissions to regulatory agencies around the globe, commonly focusing on Europe, the Middle East, and Africa.
• Ensure adherence to relevant submission standards, regulatory pathways, and regulatory strategies to facilitate efficiency of agency review.
• Support submission activities for affiliates and business partners around the globe, commonly focusing on specific geographies.
• Execute processes to promote electronic document and submission quality control.
• Maintain strong working relationships with Regulatory Affairs, members of Project Management, and publishing vendors to set submission timelines and content plans.

Essential Knowledge & Experience:
• Ability to work independently with minimal direction and within project teams to attain group goals.
• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
• Strong ability to communicate effectively in writing and verbally in English.
• Strong affinity with technology.
• Ability to multi-task across multiple projects and deliverables.
• Knowledge of different regulatory procedures and submissions in EU.
• Fluent in written and spoken business English.

Preferred Knowledge & Experience:
• Experience with managing IT systems or providing business operational support.
• Strong knowledge of document management, submission publishing and/or registration management systems.
• Basic understanding of data warehousing and reporting/analytics platforms or concepts.

• Bachelor’s Degree or equivalent.

Additional Information:
• This is a permanent, full-time position.
• This position is based in the Netherlands (Leiden).
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in our local 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, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law


Apply - Regulatory Operations Manager Netherlands