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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 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
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 regulations, making you a more attractive candidate.
✨Tip Number 2
Stay updated on global regulatory changes by subscribing to relevant newsletters and joining professional organisations. Being knowledgeable about the latest FDA, EMA, and ICH guidelines 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, as this is crucial for the Global Senior Director role.
✨Tip Number 4
Research Mantell Associates and their client’s values and mission. Tailor your conversations to reflect how your experience aligns with their goals, especially in terms of developing effective QA/RA strategies and managing cross-functional teams.
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 in the Biotech or Pharmaceutical sectors. Emphasise any leadership roles you've held 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 can mentor a team effectively.
Showcase Relevant Experience: In your application, provide examples of how you've successfully managed regulatory compliance and collaborated with cross-functional teams. Highlight any experience with M&A activities, as this is relevant to the role.
Proofread and Edit: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in the regulatory field.
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.
✨Demonstrate Leadership Skills
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 developed their skills, showcasing your ability to inspire and lead.
✨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. Highlight how you ensured regulatory compliance while maintaining strong relationships with these teams.
✨Stay Updated on Industry Changes
Being at the forefront of new regulations is crucial. Research recent changes in global regulations and be prepared to discuss their implications. This shows your proactive approach and commitment to staying informed, which is essential for the role.
