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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 industry standards.
- Why this job: Be at the forefront of regulatory changes and make a real impact in product development.
- Qualifications: Bachelor's or advanced degree in a scientific field with strong QA/RA experience in Biotech/Pharmaceutical.
- Other info: Engage with cross-functional teams and support M&A activities while ensuring compliance.
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.
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. 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 or webinars where you can meet potential colleagues and leaders in Regulatory Affairs and Quality Assurance. This can help you gain insights into the latest trends and possibly get a referral.
✨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
Prepare to discuss your leadership style and experiences in mentoring teams. Think of specific examples where you've successfully guided regulatory professionals through complex challenges. This will showcase your ability to lead effectively in the role of Global Senior Director.
✨Tip Number 4
Familiarise yourself with the company’s recent projects and any M&A activities they may have been involved in. Understanding their business strategy will allow you to tailor your discussions and show how you can contribute to their goals.
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 not only outlines your qualifications but also demonstrates your understanding of global regulations and how they impact product development. Mention your leadership style and how you have successfully mentored teams in the past.
Showcase Relevant Experience: In your application, provide specific examples of how you've developed and implemented regulatory strategies. Highlight your experience with FDA, EMA, and ICH regulations, and how you've navigated changes in these areas.
Highlight Communication Skills: Since the role requires excellent communication and interpersonal skills, include examples of how you've effectively interacted with stakeholders. This could be through leading cross-functional teams or presenting regulatory updates to senior management.
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 of RA/QA position.
✨Emphasise Leadership Experience
Since the role requires strong leadership skills, be ready to discuss your experience in managing and mentoring teams. Share stories that illustrate your ability to guide regulatory professionals and foster a collaborative environment.
✨Prepare for Cross-Functional Collaboration
This position involves working with various teams like clinical development and quality assurance. Be prepared to discuss how you've successfully collaborated with different departments in the past to ensure regulatory compliance and timely product approvals.
✨Stay Updated on Industry Changes
Demonstrate your proactive approach by discussing how you keep abreast of changes in global regulations. Mention any recent developments in the industry and how they could impact the company's operations, showcasing your strategic thinking.
