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- Tasks: Lead and mentor a team in Quality Assurance and Regulatory Affairs for a growing CDMO.
- Company: Join Mantell Associates, a specialist headhunting firm in the Pharmaceutical and Life Sciences sector.
- Benefits: Enjoy competitive salary, leadership opportunities, and a chance to shape global regulations.
- Why this job: Be at the forefront of regulatory changes and make a real impact in the biotech industry.
- Qualifications: Bachelor's or advanced degree in a scientific field with strong QA/RA experience required.
- Other info: Engage with cross-functional teams and support M&A activities in a dynamic environment.
The predicted salary is between 72000 - 108000 £ per year.
Mantell Associates is partnered with a rapidly growing CDMO, who is looking to expand their team with the addition of a Global Senior Director of RA/QA.
Responsibilities:
- Develop and implement effective Quality Assurance & Regulatory strategies by maintaining Policy and Intelligence.
- Manage and mentor a team of regulatory professionals, providing guidance and leadership to ensure adherence to global regulations and internal policies.
- Be at the forefront of new and developing regulations and guidelines.
- Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance and timely product approval.
- Responsible for providing an overview of QA/RA Policy to stakeholders and staff.
- Monitor and interpret changes in global regulations and communicate the impact on the company's products and operations.
- Ensure submission publishing is well executed and on time.
- Engage and support all relevant staff to support M&A activities.
- Proactively manage a Regulatory Affairs network externally and internally.
Requirements:
- Bachelor's or advanced degree in a scientific or medical field.
- Strong experience within Quality Assurance/Regulatory Affairs in the Biotech / Pharmaceutical space, including leadership experience.
- Thorough understanding of global regulations (FDA, EMA, ICH) and their impact on product development and approval.
- Strong leadership and management skills, with the ability to mentor and develop a team of regulatory professionals.
- Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
- Proven track record of Global Regulatory Processes.
Global Senior Director of RA/QA employer: Mantell Associates
Contact Detail:
Mantell Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Senior Director of RA/QA
✨Tip Number 1
Network with professionals in the Biotech and Pharmaceutical sectors. Attend industry conferences or webinars where you can meet people who are already in similar roles. This can help you gain insights into the latest trends and regulations, which is crucial for a Global Senior Director of RA/QA.
✨Tip Number 2
Stay updated on global regulatory changes by subscribing to relevant newsletters or joining professional organisations. Being knowledgeable about the latest FDA, EMA, and ICH guidelines will not only enhance your expertise but also demonstrate your commitment to the field during interviews.
✨Tip Number 3
Consider reaching out to current or former employees of Mantell Associates or similar companies. They can provide valuable insights into the company culture and expectations for the Global Senior Director role, helping you tailor your approach when you apply.
✨Tip Number 4
Prepare to discuss your leadership style and experiences in mentoring teams during interviews. Highlight specific examples where you've successfully guided regulatory professionals through complex challenges, as this will be key for the role you're aiming for.
We think you need these skills to ace Global Senior Director of RA/QA
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Quality Assurance and Regulatory Affairs, particularly within the Biotech or Pharmaceutical sectors. Emphasise any leadership roles and specific achievements that align with the responsibilities of the Global Senior Director position.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your understanding of global regulations and your experience in managing teams. Use specific examples to demonstrate how you've successfully navigated regulatory challenges and contributed to product approvals.
Highlight Relevant Skills: In your application, focus on key skills such as leadership, communication, and your ability to interpret and implement regulatory changes. Mention any experience you have with cross-functional collaboration, as this is crucial for the role.
Showcase Continuous Learning: Mention any ongoing education or training related to regulatory affairs and quality assurance. This could include certifications, workshops, or conferences that keep you updated on the latest regulations and industry trends.
How to prepare for a job interview at Mantell Associates
✨Showcase Your Regulatory Expertise
Make sure to highlight your deep understanding of global regulations such as FDA, EMA, and ICH. Prepare specific examples of how you've navigated these regulations in past roles, as this will demonstrate your capability to manage compliance effectively.
✨Demonstrate Leadership Skills
As a Global Senior Director, you'll need to lead and mentor a team. Be ready to discuss your leadership style and provide examples of how you've successfully developed and guided teams in the past, especially in high-pressure environments.
✨Prepare for Cross-Functional Collaboration
This role requires collaboration with various departments. Think of instances where you've worked with clinical development, medical affairs, or quality assurance teams. Be prepared to discuss how you ensured regulatory compliance while meeting project deadlines.
✨Stay Updated on Industry Changes
Being at the forefront of new regulations is crucial. Research recent changes in the regulatory landscape and be ready to discuss their implications. This shows your proactive approach and commitment to staying informed in the field.
