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Associate Director Regulatory Affairs

2018-11-05 Astellas Pharma Europe B.V. | Leiden | HBO | Fulltime | Sluit 2019-01-04

Are you a hands-on qualified regulatory affairs professional with an interest for nephrology and urology?

Are you able to play a key role in an international organization and influence and coordinate strategy in this challenging role within regulatory affairs? Then Astellas has an interesting job opportunity for you!

Associate Director Regulatory Affairs
Fulltime, 40 hours, Leiden, The Netherlands

Your job as an Associate Director Regulatory Affairs - EMEA
This position plays a key role in the regulatory affairs department. You are responsible for defining EMEA regional regulatory strategy for development compounds and life cycle management and can be a member of several project teams. You are a regulatory project leader who drives development, maintenance and submission related activities and you execute product regulatory strategies successfully.

The role is highly analytical and complex; you work on strategic, diverse problems, with decision making that has functional or corporate impact. You need to influence and communicate clearly, as actions may have serious implications on operations, revenue, and/or credibility. In this position you anticipate regulatory issues for assigned projects and manage them proactively.

As an associate director you are a senior regional regulatory leader who works in multifunctional project teams. Astellas Pharma is a global organization; you will interact with people from other disciplines involved in drug development and LCM. You to be able to work independently and as part of a team.

You will work in the Specialty Medicine therapeutic area with focus on nephrology and urology compounds/medicines and you provide expertise in directing projects within these therapeutic fields. The role includes contact with Regulatory Affairs and Operations Medical Affairs, Legal, Commercial, Market Assess, Clinical Research and Development, Chemistry Manufacturing and Controls (CMC), Advertising/Labeling, and the extended Global Project Teams.

Your personal qualifications as an Associate Director Regulatory Affairs

  • Bachelor’s degree in scientific discipline; advanced degree preferred.
  • previous pharmaceutical drug development experience,
  • 6 years regulatory affairs experience preferably involving direct contact with the EMA, CHMP, National Agencies; full knowledge of CHMP and ICH regulations and guidelines, and the ability to provide interpretations to others.

You have strong organizational skills with the ability to manage large a diverse workload and provide regulatory guidance/training to others. As a multitasker you have the ability to communicate effectively and maintain effective working relationships. You must be able to have a positive influence on the department staff and behave with a high integrity. The role requires excellent and oral communication skills

We offer

  • A challenging and diversified job
  • Inspiring work climate
  • Attractive remuneration, which includes:
    o a 13th month
    o excellent pension policy
    o health insurance compensation
    o collective health insurance
    o company own saving scheme arrangement
    o 25 Holidays + 13 so called ADV Days
    o and more….

At Astellas, we believe that nurturing a good relationship with our employees delivers good business results.
It is our stated aim in the VISION for Astellas to be recognised as an Employer of Choice. This means ensuring we are a highly effective organisation, that applies best-in-class people management, creates a positive working environment and has an inspirational company culture.. This reflects the working culture of Astellas, outlines our expectations as an employer and captures the essence of our company ethos; CHANGING TOMORROW.

About Astellas
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products.
Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.

Mirai House, located in Leiden Bio Science Park, is home to a number of divisions, including the European R&D organization focusing on the development of medicines in the areas of Urology, Nephrology, Pain, and Diabetes/Metabolic diseases.

In Leiden Bio Science Park about 93 companies together with research institutes, Leiden University and the LUMC are dedicated to the development of innovative drugs, vaccines, diagnostics and platform technologies.

A VOG and/or background check can be part of the recruitment process.

Interested? Please apply via the ''Apply'' button.

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