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- Tasks: Manage submissions and lifecycle processes for regulatory documents across EMEA.
- Company: BeOne Medicines is a forward-thinking biotech company focused on innovative therapies.
- Benefits: Enjoy flexible working options, competitive salary, and a diverse workplace culture.
- Why this job: Join a dynamic team making a real impact in healthcare with exciting challenges.
- Qualifications: Bachelor's degree in a scientific field and 3-5 years in regulatory affairs required.
- Other info: Opportunity for supervisory roles and collaboration with global teams.
The predicted salary is between 43200 - 72000 £ per year.
This position supports the EMEA regional lead by managing the preparation and submission of CTAs/MAAs and lifecycle management in both paper and electronic formats to Health Authorities across Europe, Middle East, and Africa. Experience with submissions to US, Canada, and Asia Pacific regions is preferred.
The role involves developing streamlined submission processes, ensuring quality checks, and reporting metrics based on industry best practices. The successful candidate will develop and maintain cross-functional relationships to ensure high-quality, timely, and compliant submissions.
Responsibilities include overseeing document processes, submission publishing, resource allocation, and supporting regulatory documentation management. The role requires extensive knowledge of regulatory submission processes, project management skills, and familiarity with tools like Veeva Vault RIM, Veeva Publishing, and various regulatory portals.
Qualifications include a Bachelor's degree in a relevant scientific discipline, 3-5 years of experience in biotech or pharma regulatory affairs, and proven success in regulatory submissions. Supervisory responsibilities may be involved.
Proficiency in MS Office, Adobe, and regulatory information systems is required. The role also emphasizes global competencies like teamwork, initiative, adaptability, and clear communication.
BeOne Medicines is an equal-opportunity employer committed to diversity and inclusion.
Manager, Submissions Operations Management - EMEA employer: BeOne Medicines
Contact Detail:
BeOne Medicines Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Submissions Operations Management - EMEA
✨Tip Number 1
Familiarise yourself with the specific regulatory submission processes in the EMEA region. Understanding the nuances of CTAs and MAAs will give you an edge during discussions and interviews.
✨Tip Number 2
Network with professionals in the biotech and pharma industries, especially those who have experience with submissions. Engaging with them can provide insights and potentially lead to referrals.
✨Tip Number 3
Demonstrate your project management skills by preparing examples of how you've successfully managed submission processes in the past. Be ready to discuss these experiences in detail during your interview.
✨Tip Number 4
Showcase your familiarity with tools like Veeva Vault RIM and Veeva Publishing. If you have any certifications or training in these systems, make sure to highlight them when discussing your qualifications.
We think you need these skills to ace Manager, Submissions Operations Management - EMEA
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the key responsibilities and qualifications required for the Manager, Submissions Operations Management role. Tailor your application to highlight relevant experiences that align with these requirements.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in regulatory submissions, particularly in biotech or pharma. Mention specific projects where you managed submission processes or developed streamlined operations, showcasing your project management skills.
Showcase Technical Skills: Make sure to include your proficiency with tools like Veeva Vault RIM and Veeva Publishing in your application. If you have experience with regulatory portals or other relevant software, mention this as well to demonstrate your technical capabilities.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also reflects your understanding of the importance of compliance and quality in submissions. Use clear communication to convey your enthusiasm for the role and how you can contribute to BeOne Medicines.
How to prepare for a job interview at BeOne Medicines
✨Know Your Regulatory Submissions
Make sure you have a solid understanding of the regulatory submission processes, especially for CTAs and MAAs. Be prepared to discuss your previous experiences with submissions in both paper and electronic formats, as well as any specific challenges you've faced.
✨Showcase Your Project Management Skills
Highlight your project management experience during the interview. Discuss how you've successfully managed timelines, resources, and cross-functional teams in past roles, particularly in the biotech or pharma sectors.
✨Familiarise Yourself with Relevant Tools
Since familiarity with tools like Veeva Vault RIM and Veeva Publishing is essential, be ready to talk about your experience with these systems. If you haven't used them directly, research their functionalities and be prepared to discuss how you would adapt to using them.
✨Emphasise Teamwork and Communication
Given the importance of cross-functional relationships in this role, be sure to provide examples of how you've effectively collaborated with others. Highlight your communication skills and adaptability, as these are key competencies that BeOne Medicines values.
