Do you have experience in pharmaceutical labeling and strong organizational skills? Then Astellas has an interesting job opportunity for you.
As an Associate Regulatory Labeling Director in the Regulatory Affairs department, you will be responsible for oversight of development, implementation, and change control of new and revised labeling for assigned Astellas products worldwide. You will ensure compliance with CCDS, applicable regional health authority requirements and internal regional business partners on best practices regarding planning and execution of labeling strategies. Advise global internal stakeholders and business partners on best practices regarding planning and execution of labeling strategies. The Associate Regulatory Labeling Director collaborates to assure labeling-relevant aspects of global and local regulatory strategies reflect best in class applications and programs meet all applicable regulatory and business requirements. You will be responsible for the training and managing of regulatory staff as required.
You are responsible for:
As an Associate Regulatory Labeling Director, you have strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse project simultaneously.
You must be able to effectively influence peers both inside and outside the organization and maintain effective working relationships. You also have excellent interpersonal written and verbal communications skills in English.
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.
Astellas is a Japanese multinational pharmaceutical company employing over 16,500 people worldwide with global sales exceeding 11 billion euro. The group's EMEA headquarters are based in the UK, with affiliates throughout Europe engaged in supply chain, manufacturing and sales & marketing. With over 4,200 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.
Please apply via the 'Apply' button. A VOG and/or background check can be part of the recruitment process.