Associate Regulatory Labeling Director

Astellas Pharma Europe B.V.

Associate Regulatory Labeling Director

Fulltime

Astellas Pharma Europe B.V.

Leiden, Netherlands

Do you have experience in pharmaceutical labeling and strong organizational skills? Then Astellas has an interesting job opportunity for you.

Your job as an Associate Regulatory Labeling Director

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:

  • Managing the implementation of new and updated printed packaging components for Astellas locations worldwide;
  • Independently managing the systems, processes, and operations for development of and changes to labeling;
  • Advising cross-functional teams on labeling content consistency and best practices regarding planning and execution;
  • Represent Regulatory Affairs in cross-functional initiatives such as committees, training initiatives, due diligence assessments, etc.;
  • Actively support the systems, processes, and operations for development of and changes to labeling, and assure compliance to those procedures;
  • Establish strong working relationships with local and global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply;
  • Manage direct reports.

Your personal Qualifications as an Associate Regulatory Labeling Director

  • Bachelor's degree, preferably in Life Science;
  • At least 8 years previous industry experience; 5 in Regulatory Affairs;
  • Demonstrated expert proficiency in managing and control of pharmaceutical labeling in accordance with local and global regulatory requirements. Direct pharmaceutical labeling development experience with demonstrated proficiency in managing change control;
  • Proven proficiency with relevant FDA/ICH and other local health authority regulations and guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations.

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.

We offer

  • A challenging and diversified job in an international setting;
  • Good career opportunities;
  • An inspiring and dynamic work climate;
  • 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.

About Astellas

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.

Interested?

Please apply via the 'Apply' button. A VOG and/or background check can be part of the recruitment process.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Netherlands     Clinical Research     Manager and Executive     Regulatory Affairs     Astellas Pharma Europe B.V.    

© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies