Partner, Regulatory Affairs, Regulatory Product Information Management

Partner, Regulatory Affairs, Regulatory Product Information Management

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.

The Opportunity:

As the Partner, Regulatory Affairs, Regulatory Product Information Management, you apply across the three sections within Regulatory Operations: Regulatory Product Information Management, Publishing & Submission, and Data Governance and Compliance. In this role, it is expected that you focus on one of these key areas and should have substantial knowledge of all areas. Your main responsibilities include organizing regulatory operations aspects of projects/products, including managing the planning, preparation, submission, and tracking of correspondence, applications, and other structured data to regulatory agencies. You will be identifying and ensuring adherence to relevant submission standards and initiating/maintaining relationships with key personnel within the global Regulatory Affairs organization to resolve procedural and operational complexities and identify process improvements. Your responsibilities also involve strategic and execution-focused interactions with multiple regional health authorities and other Astellas functions such as Pharmacovigilance, Marketing Operations, Data Science, Supply Chain, Manufacturing, 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:

• Support the accuracy and completeness of global Regulatory Product data, metadata and other regulatory information in collaboration with data owners by authoring and/or reviewing the quality documents and other reference material and that adhere to the relevant data standards and industry best practices (i.e. Data Steward role)
• Maintain the daily operation of the global Regulatory Information Management system including data entry, quality control and metrics.
• Manage and creates business processes to capture/track regulatory events/information into regulatory database according to local regulatory requirements
• Gather Regulatory information to systems inside or outside of RA according to system integration logic.
• Support controlled vocabulary management across RA systems, in conjunction with the Data Governance and Compliance team.
• Delivers reports sharing Regulatory information with cross-functional stakeholders including Pharmacovigilance, Medical Affairs, Development Operations, Finance and senior and top management.

Essential Knowledge & Experience:

• Significant 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.
• Strong and effective communication skills, ability to establish and maintain productive working relationships, and influence peers and others in the organization.
• Ability to work independently with minimal direction and coordinate priorities and tasks within project teams, committees, etc. to attain group goal.
• High integrity to maintain confidential and proprietary information.

Preferred Knowledge & Experience:

• Experience with managing IT systems.
• Demonstrated proficiency using 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.

Educations/Qualifications:

• Master’s Degree or equivalent.

Additional Information:

• This is a permanent, full-time position.
• This position is based in the Netherlands and UK.
• Fluent in written and spoken business English.
• 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.