Regulatory Affairs Trainee

Regulatory Affairs Trainee

About Astellas:

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

We pursue innovative science, focusing 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 caregivers, 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 Regulatory Affairs Trainee at Astellas, you will play a vital role in facilitating regulatory expertise and executing regulatory strategy and activities. Your primary responsibilities will include liaising with local Health Authorities, managing product information and artwork, and ensuring regulatory compliance with Astellas policies and regional/local regulations. Under supervision, you will contribute to the submission process, follow up accordingly, and assist in preparing local submission documents.

Additionally, you will be involved in regulatory information management, including systems updates both internally and externally, as well as product information and artwork management. Furthermore, you will collaborate with various internal stakeholders such as Pharmacovigilance, Quality Assurance, and Supply Chain, while also beginning to develop external relationships and networks across other companies within the regulatory landscape.

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.

In this role, you will:

• Assist in making submissions to the national authority and follow up accordingly, under supervision.
• Perform local tasks related to EU centralized licenses, such as translations.
• Manage regulatory information, including updating internal and external systems.
• Oversee product information (SmPC/aPI/PIL/aRMM) and artwork management.
• Ensure the approved Summary of Product Characteristics (SmPC) or leaflets are available for internal and external use.

Essential Knowledge & Experience:

• Basic understanding of regulatory affairs and the regulatory landscape within the EU.
• Proficiency in the English language.
• Strong aptitude to build knowledge and support a team, with demonstrable attention to detail.

Education:

• Pharmacist degree or equivalent.

Preferred Knowledge & Experience:

• Effective communication skills and the ability to collaborate with diverse internal and external stakeholders.
• Proactive approach to learning and development, with a keen interest in regulatory compliance and pharmaceutical regulations.
• Ability to interpret scientific data and make recommendations, contributing to the review of promotional materials in line with local codes.

Additional information:

• This is a part-time position: 2 days per week (Mondays and Thursdays, but negotiable).
• This position follows our hybrid model. Role requires a blend of home (preferably on Mondays) and a minimum of 1 day per week in our Dublin office (preferably on Thursdays). 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, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.