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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 Pharmaceuticals and Life Sciences.
- 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 in exciting M&A activities and collaborate with cross-functional teams.
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.
For more information on this role, please contact us at 44 (0)20 3854 7700.
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 and seminars to meet potential colleagues and leaders in Regulatory Affairs and Quality Assurance. This can help you gain insights into the latest trends and possibly get referrals.
✨Tip Number 2
Stay updated on global regulations, especially those from the FDA, EMA, and ICH. Subscribe to relevant newsletters or join online forums where these topics are discussed. Being knowledgeable about current changes will demonstrate your commitment and expertise during interviews.
✨Tip Number 3
Showcase your leadership skills by engaging in mentorship opportunities within your current role. Highlight any experience you have in managing teams or projects, as this is crucial for a senior director position. This will set you apart as a candidate who can lead and inspire others.
✨Tip Number 4
Prepare to discuss specific examples of how you've navigated regulatory challenges in the past. Be ready to explain your thought process and the outcomes of your decisions. This will illustrate your problem-solving abilities and your understanding of the complexities involved in RA/QA.
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, especially 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 showcases your understanding of global regulations and your ability to lead a team. Mention specific examples of how you've successfully managed regulatory compliance and product approvals in the past.
Highlight Relevant Skills: In your application, clearly outline your strong communication and interpersonal skills. Provide examples of how you've effectively collaborated with cross-functional teams and engaged stakeholders in previous roles.
Showcase Continuous Learning: Demonstrate your commitment to staying updated on new and developing regulations. Mention any relevant training, certifications, or professional development activities that reflect your proactive approach to regulatory affairs.
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 lead in the Global Senior Director position.
✨Emphasise Leadership Experience
Since the role involves managing and mentoring a team, be ready to discuss your leadership style and experiences. Share instances where you successfully guided a team through regulatory challenges or implemented effective QA strategies.
✨Prepare for Cross-Functional Collaboration
This position requires collaboration with various teams. Think of examples where you've worked with clinical development, medical affairs, or quality assurance teams to ensure compliance. This will show your ability to work effectively across departments.
✨Stay Updated on Industry Changes
Be prepared to discuss recent changes in global regulations and how they might impact the company. Showing that you are proactive about staying informed will reflect your commitment to the role and the industry.
