Associate Director, Regulatory Affairs - Global / EU Development Strat
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Associate Director, Regulatory Affairs - Global / EU Development Strategy Astellas - Oncology Global Development
Fulltime, 40 hours, Leiden, The Netherlands
Your job as an Associate Director, Regulatory Affairs
As Associate Director Regulatory Affairs you are responsible for multiple regulatory activities, and accountable for the development and implementation of the regulatory strategy for an oncology product/group of products. Within a matrix organization, you will ensure that the regulatory strategy is developed for review by a multi-functional global team, to ensure expedited approval with competitive labeling in keeping with the product profile, business goals and patient needs. You will lead submission-related activities, and successfully execute regulatory strategies. You ensure that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. You review regulatory submissions for accuracy, consistency and quality. Furthermore you are responsible for significant interactions outside the regulatory affairs department on complex issues and questions. You work closely with other individuals/groups within Regulatory Affairs to influence others to ensure departmental consistency, and identify options for risk discussions. Next to this you provide regulatory expertise in directing projects within oncology, including International Regulatory Support, Clinical Research and Development, Chemistry Manufacturing and Controls, Advertising/Labeling, Regulatory Operations and to the Global Project Team. As Associate Director Regulatory Affairs you serve on increasingly more significant project teams/task forces, with a view to accumulating experience which allows for career progression at a pace in keeping with your contribution, value and the business opportunities.
Your personal qualifications as an Associate Director, Regulatory Affairs
At least bachelor degree in scientific discipline; advanced degree preferred A minimum of 9 years previous pharmaceutical drug development experience, including previous experience in attending and/or helping a team prepare for agency interactions (e.g. FDA advisory committee meetings, Oral explanations, EoP2 Meetings, Scientific Advice, Pre-Submission Meetings, etc), and experience in submissions for PIPs, CPs, and a sound understanding of PRIME, ODD, etc. Proven record of successful submissions and negotiations with the local authorities in areas of CMC and product formulations, particularly in biotechnology/biological products, and an enthusiasm for competitive developments in new technologies relevant to the oncology landscape. Recognized as an expert in regulatory aspects of drug development involving undefined frameworks with technical complexity and broad scope. Scientific knowledge in CMC, general biological/physical science, clinical development, and an ability to apply that knowledge to regulatory issues and product development.
As Associate Director Regulatory Affairs you have strong organizational skills with the ability to manage large projects, with a high degree of efficiency and time management. You have proven abilities to prioritize and multi-task with minimal supervision based on interactions with project team members. You will have responsibility as a Global Regulatory Lead or Regional Regulatory Lead, ensuring that regional regulatory needs for oncology products are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Development Plan. You will lead and/or participate to the ongoing assessment of emerging data and communicate appropriately to senior management on regional project impacts and risk mitigation strategies.
Furthermore you have high integrity with respect to maintenance of proprietary, confidential information. As Associate Director Regulatory Affairs you have excellent interpersonal written and verbal communication skills in English with writing ability to meet regulatory requirements and standards.
A challenging and diversified job in a team of professionals Good career development opportunities Inspiring and dynamic work climate in a global organization Attractive remuneration, which includes:
a 13th month excellent pension policy health insurance compensation collective health insurance company own saving scheme arrangement 25 Holidays + 13 so called ADV Days 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.
Astellas is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding 10billion 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 900 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. It is the location where the majority of offices and clean rooms and labs are located.