General Information

Job Advert Title
MEAR Junior Product Manager
Location
Netherlands
Function/Business Area
Regulatory Affairs
Department
Emerging Markets Sub Region RA
Employment Class
Permanent

Description

MEAR Junior Product 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 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:

  • This position coordinates the development, preparation and implementation of regulatory strategies to maintain, and extend product development and registrations in the INTL-GCN region, in alignment with Therapeutic Areas for maintenance activities.
  • Provides proactive guidance to internal groups, affiliates and/or business partners based on technical and regulatory knowledge towards development of strategic and tactical plans throughout the lifecycle of the product.

Key Activities are noted below:

  • This position coordinates the development, preparation and implementation of regulatory strategies to maintain, and extend product development and registrations in the INTL-GCN region, in alignment with Therapeutic Areas for maintenance activities.
  • Provides proactive guidance to internal groups, affiliates and/or business partners based on technical and regulatory knowledge towards development of strategic and tactical plans throughout the lifecycle of the product.
  • Collaborates with Therapeutic Areas, CMC-RA, PTech, QA, RA operations and CCDS labeling on global/regional regulatory strategies and with Astellas functions for regional programs and products.
  • Provides input for RA cross functional projects from region. Actively works with project management and Regulatory Operations to ensure appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across indications and compounds in the Region. Provides updates and manages assigned regulatory submission timelines using the appropriate project management tools.
  • Coordinates and monitors the preparation of administrative documents and GMP (Good Manufacturing Practice) related documents for various submissions including, but not limited to, Company registration applications, GMP inspections applications, Marketing Authorization Applications (MAAs) and their maintenance, in collaboration with internal and external manufacturing sites, CMC-RA, Ptech, QA and Affiliates / Business Partners, as applicable.
  • Develops professional relationships and acts as main contact with internal and external manufacturing sites for administrative and GMP related documents requests.
  • Provides guidance to all appropriate departments to ensure compliance with applicable regulations. Remains knowledgeable about current regulations and guidance, including interpretation of regulations/guidance and notification of appropriate Astellas personnel.
  • Contribute to regulatory and other company-wide and departmental policies and standard operating procedures.
  • Interacts with peers in other regions within RA-INT to ensure alignment any synergy of strategies.

Experience and Knowledge:

  • Previous experience in pharmaceutical companies or equivalent.
  • Previous experience with submissions in the Sub-Region.
  • If applicable: Fluent in English, Spanish or other relevant languages appropriate to the sub-region.
  • Strong scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development. Recognized as an expert in an aspect of pharmaceutical drug development.

Qualifications:

  • Bachelor’s degree in scientific discipline required; advanced degree preferred.

Additional information:

  • Currently this position has the flexibility to work from home and in the office.
  • This is a permanent full-time position based in the Netherlands.

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.