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Senior Regulatory Affairs Operations Manager

Employer
Astellas Europe
Location
Leiden (Gemeente), Zuid-Holland (NL)
Salary
Competitive+Benefits
Start date
6 Sep 2022
Closing date
6 Oct 2022

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details

Senior Regulatory Affairs Operations Manager

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

About this job

As a Senior Regulatory Affairs Operations Manager you will:

  • Support the accuracy and completeness of global regulatory product data and other regulatory information by authoring and/or reviewing the quality documents and other reference material and that adhere to the relevant data standards and industry best practices
  • Support and create business processes to capture/track regulatory events/information into regulatory database according to local regulatory requirements
  • Deliver reports sharing Regulatory information with cross-functional stakeholders including Pharmacovigilance, Medical Affairs, Development Operations, Finance and senior and top management
  • Support the daily operation of the global Regulatory Information Management system including data entry, quality control and metrics
  • Support controlled vocabulary management across Regulatory Affairs systems, in conjunction with the Data Integration and Optimization Regulatory Operations team
  • Support and collaborate with Regulatory Affairs stakeholders in order to provide regulatory information to other systems or outside of Regulatory Affairs according to system integration logic
  • Communicate and collaborate with Regulatory Affairs stakeholders in order to capture regulatory event information in a timely manner
  • Provide overviews/reports to stakeholders and identify ways to improve completeness and accuracy
  • Oversee the process and ensure the creation and transmission of data-centric regulatory submissions such as XEVMPD and IDMP

Essential Knowledge & Experience:

  • At least 5 years’ experience in a regulatory operations role or similar position associated with regulated processes and content in the pharma industry
  • Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed

Preferred Knowledge/Experience/Qualifications:

  • Ability to work independently with minimal direction and coordinate priorities and tasks within project teams, committees, etc. to attain group goal
  • Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members
  • Ability to communicate effectively, establish and maintain productive working relationships, and influence peers and others in the organization

Education/Qualifications:

  • Bachelor’s degree (science or technology is preferred)
  • Experience with managing IT systems
  • Demonstrated proficiency using document management, submission publishing, registration management, labeling, quality control and/or change control systems
  • Basic understanding of information taxonomies, master data management or other structured data constructs
  • Basic understanding of data warehousing, data lakes and reporting/analytics platforms or concepts

Additional information:

  • Full time
  • Location: The position is based in Leiden, Netherlands

We offer:

  • A challenging and diversified job in an international setting
  • Opportunity and support to continuous development
  • Inspiring work climate

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.

Company

At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional results. 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.

For more information about our current career opportunities and how you can make a difference please visit https://www.astellas.com/eu/careers

Find Us
Website
Location
300 Dashwood Lang Road,
Bourne Business Park
Addlestone
KT15 2NX
GB
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