Regulatory Affairs & Pharmacovigilance Manager

About Astellas:

At Astellas we are making treatments that matter to people.

We are tackling the toughest health challenges putting the patient at the heart of every move we make.

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 have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.

We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.

From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.

About this job:

The main role of the Regulatory Affairs Manager is to take part in affiliate product and launch teams to provide regulatory input and strategy advice, be the key contact for the competent authorities for Hungary in Regulatory Affairs and Pharmacovigilance matters.  In addition, this role is responsible for development and maintenance of excellence in Pharmacovigilance (PV) activities at the local affiliate in Hungary.

As a Regulatory Affairs & Pharmacovigilance Manager you will be responsible for:

• Timely prepare, submit and conduct appropriate follow-up of new Marketing Authorization and Life Cycle Management through timely preparation and/or submission of variations, renewals or supplements to the national competent authorities.
• Provide regulatory guidance to multidisciplinary teams to ensure that development or maintenance activities to be performed in the context of approved business activities are performed in time and in compliance with applicable regulatory demands (legislation and guidelines) throughout the product’s life cycle. For assigned products ensures high quality labelling translation and compliant printed packaging materials of marketed products.
• Ensure regulatory compliance with Astellas policies, EU and local regulations and guidance.
• Develop and maintain professional relationship with relevant external contacts such as governmental bodies and pharmaceutical industry association, where appropriate.
• Management of Product Safety Information.
• Ensuring quality and compliance for pharmacovigilance.
• Responsible for acting as the local Drug Safety Officer (DSO) and manage its related duties.

Essential Knowledge & Experience:

• Relevant minimum 4 years experience within Pharmacovigilance and Regulatory Affairs; to include direct contact and engagement with national competent authorities.
• Knowledge of Regulatory landscape and procedures within Hungary.

Preferred Knowledge/Experience/Qualifications:

• Work experience in transversal projects.
• Knowledge in European Regulations for Pharmaceutical Industry.

Education/Qualifications:

• Degree in Pharmacy or other  Life Science or equivalent by experience. 
• Proficiency in Hungarian and English language

Additional information:

• Full time
• Minimum travel is expected, mainly based in Astellas Hungary HQ in Budapest.

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