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- Aufgaben: Lead European regulatory strategy for oncology projects and collaborate globally.
- Arbeitgeber: Daiichi Sankyo is dedicated to improving patients' lives through innovative healthcare solutions.
- Mitarbeitervorteile: Enjoy a culture of respect, continuous learning, and opportunities for personal growth.
- Warum dieser Job: Make a real impact in patients' lives while working in a diverse and inclusive environment.
- Gewünschte Qualifikationen: 10+ years in pharma, with expertise in global regulatory affairs and oncology.
- Andere Informationen: Join a team that values bold thinking and proactive problem-solving.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary global product team, providing expertise on regulatory matters. Represent Regulatory Affairs in external interactions (e.g. authorities, affiliates, partners, CROs) providing expertise on regulatory strategy to achieve regional and global goals.
Roles & Responsibilities:
- European regulatory strategy support for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management.
- European Regulatory Affairs representation on global project teams providing regulatory guidance and strategy and supporting EU MAA submissions.
- Act as regulatory contact person for authorities for assigned projects.
- Participate in assigned non-project tasks and process improvements.
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders.
Education & Professional Experience:
- Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus.
- Minimum of 10 years of experience in the pharmaceutical industry and minimum of 8 years of experience in global regulatory affairs with emphasis on early stage drug development and marketing authorization applications in Europe, experience with clinical trials, orphan drugs and paediatric clinical development.
- Experience of working in a global environment as well as with National Health Agencies and EMA.
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation.
- Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner.
- Solution- and detail-oriented; well organised and self-motivated.
- Excellent written and oral communication skills in English, second language preferred.
Why work with us?
Working at Daiichi Sankyo is more than just a job - it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
For more information: www.daiichi-sankyo.eu
Director Regulatory Affairs Oncology (m/f/x) Arbeitgeber: Daiichi Sankyo Europe GmbH
Kontaktperson:
Daiichi Sankyo Europe GmbH HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Director Regulatory Affairs Oncology (m/f/x)
✨Tip Number 1
Make sure to highlight your experience in global regulatory affairs, especially in early-stage drug development and marketing authorization applications. This is crucial for the role, so be ready to discuss specific projects where you've successfully navigated these processes.
✨Tip Number 2
Demonstrate your ability to work cross-functionally in a multinational environment. Prepare examples of how you've collaborated with diverse teams and managed relationships with various stakeholders, including health agencies and partners.
✨Tip Number 3
Stay updated on current regulatory trends and guidelines in oncology. Being knowledgeable about recent changes will not only help you in discussions but also show your commitment to the field and readiness to adapt strategies accordingly.
✨Tip Number 4
Prepare to showcase your solution-oriented mindset. Think of instances where you've identified challenges in regulatory processes and how you approached them effectively. This will demonstrate your proactive attitude and problem-solving skills.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Director Regulatory Affairs Oncology (m/f/x)
Tipps für deine Bewerbung 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, especially in oncology and early-stage drug development. Emphasize your 10+ years in the pharmaceutical industry and any specific projects that align with the job description.
Craft a Compelling Cover Letter: In your cover letter, express your passion for making a difference in patients' lives. Discuss your experience with European regulatory strategy and how it aligns with Daiichi Sankyo's goals. Be sure to mention your ability to work cross-functionally and your intercultural skills.
Showcase Relevant Experience: When detailing your professional experience, focus on your roles involving clinical trials, orphan drugs, and marketing authorization applications. Provide specific examples of how you've successfully navigated regulatory challenges in a global environment.
Highlight Communication Skills: Since excellent written and oral communication skills are crucial for this role, include examples of how you've effectively communicated complex regulatory information to various stakeholders, including authorities and project teams.
Wie du dich auf ein Vorstellungsgespräch bei Daiichi Sankyo Europe GmbH vorbereitest
✨Show Your Regulatory Expertise
Make sure to highlight your extensive experience in global regulatory affairs, especially in oncology. Be prepared to discuss specific projects you've worked on, particularly those involving early-stage drug development and marketing authorization applications.
✨Demonstrate Cross-Functional Collaboration
Since the role requires working within a multi-disciplinary global product team, share examples of how you've successfully collaborated with different departments. Emphasize your ability to communicate effectively across functions and cultures.
✨Stay Updated on Regulations
Be ready to discuss recent changes in regulatory guidelines and how they impact the industry. Showing that you keep current with regulations will demonstrate your commitment to the field and your proactive approach.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in previous roles and how you navigated them, particularly in relation to regulatory strategy and compliance.
