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Associate Director Regulatory Affairs

Vacaturenummer: A2100143
Astellas Pharma Europe B.V. - Leiden (Nederland)

For our client, Astellas Pharma Europe B.V., we are looking for an Associate Director Regulatory Affairs.

Keywords

  • Regulatory Affairs
  • Life-cycle management
  • Contact with health autorities
  • Due diligences processes


Profile
Are you a hands-on qualified regulatory affairs professional with a broad interest for divestment projects? In this role you are able to play a key role in an international organization and influence and coordinate the scientific and regulatory strategy. As an associate director you represent the operational status of the products and you will go through the whole life cycle and the execution of submission. You will work in the field of small molecules and you provide drug and/or drug-device expertise in directing projects within these therapeutic areas. The role includes contact with Health Authorities, Affiliates, International Regulatory Support, Clinical and Medical affairs, PharmacoVigilance, Chemistry Manufacturing and Controls (CMC), Advertising/Labeling, Regulatory Operations and to the Global Project Team.
Responsibiliites:
  • Develop challenging strategies for new assignments outside of existing regulatory;
  • Are the manager who drives submission related activities;
  • Execute regulatory strategies successfully.

The position 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.


Who we're looking for
Your personal qualifications as an Associate Director Regulatory Affairs:
  • At least an MSc. degree in scientific discipline;
  • 9 years previous pharmaceutical life-cycle management experience;
  • 6 years regulatory affairs experience preferably involving direct contact with the Health authorities such as EMA, FDA, and/or PMDA; you have full knowledge of country/regional and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
  • High experience in divestment projects worldwide developing regulatory strategies and the execution;
  • Experience in due diligences processes and in writing/reviewing agreements is a must;
  • Experience in planning and executing MA withdrawals worldwide is a plus.

You have strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed. 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 needs an excellent writer and oral communicator, to meet the regulatory requirements and standards.


Company profile
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.


Additional vacancy information
Reference:A2100143
Contract:Temporary contract with CLS Services
Education:HBO/BSc. WO/MSc. PhD.
Employment terms:Position for at least 6 months, extension possible.
Hours: 32-40
Salary: > 5500
Days of leave: 25 + 13
See here our other employment terms for this vacancy
Publication date:1-7-2021
Location:View location with Google Maps
Contactperson:Aniek Vugts
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.