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- Tasks: Lead global regulatory strategies for chemistry, manufacturing, and controls of products.
- Company: Join a dynamic team focused on innovative healthcare solutions in London.
- Benefits: Enjoy competitive pay, flexible working options, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while collaborating with diverse teams and experts.
- Qualifications: Bachelor's degree in a relevant life-science field; experience in regulatory submissions preferred.
- Other info: EU work permit required; ideal for those passionate about regulatory affairs.
The predicted salary is between 43200 - 72000 £ per year.
General Summary: The Regulatory Chemistry Manufacturing Controls (CMC) Manager will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.
Key Duties and Responsibilities:
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Contributes to the development of global regulatory CMC strategies for investigational and/or commercial products
- Works with regulatory colleagues in development of global regulatory CMC strategies and submissions
- Provides regulatory CMC guidance to cross-functional teams and key stakeholders
- Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
- Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
Knowledge and Skills:
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Experience in the preparation, including writing, of CMC submissions
- Strategic thinking and strong problem-solving skills
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Capable of strategic thinking with ability to resolve complex and ambiguous situations
- Sound knowledge of cGMP, FDA, EMA, ICH.
Education: Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field.
Regulatory CMC (Chemistry, Manufacturing, Controls) Manager employer: Vertex
Contact Detail:
Vertex Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory CMC (Chemistry, Manufacturing, Controls) Manager
✨Tip Number 1
Network with professionals in the regulatory field, especially those who have experience with CMC submissions. Attend industry conferences or webinars to meet potential colleagues and learn about the latest trends and challenges in regulatory affairs.
✨Tip Number 2
Familiarise yourself with the specific regulatory guidelines from agencies like the FDA, EMA, and ICH. Understanding these regulations will not only enhance your knowledge but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Consider reaching out to current or former employees of StudySmarter on professional networking sites. They can provide insights into the company culture and expectations for the Regulatory CMC Manager role, which can be invaluable during your application process.
✨Tip Number 4
Prepare to discuss specific examples of how you've successfully navigated complex regulatory challenges in past roles. This will showcase your problem-solving skills and strategic thinking, both of which are crucial for the position.
We think you need these skills to ace Regulatory CMC (Chemistry, Manufacturing, Controls) Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory CMC Manager position. Tailor your application to highlight relevant experiences that align with the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with regulatory submissions, particularly in CMC. Mention specific projects or roles where you influenced regulatory strategies or worked with cross-functional teams.
Showcase Your Skills: Demonstrate your strong interpersonal skills and strategic thinking in your application. Provide examples of how you've successfully communicated complex information or resolved challenging situations in previous roles.
Tailor Your Documents: Customise your CV and cover letter for this specific role. Use keywords from the job description, such as 'regulatory guidelines', 'GMP', and 'problem-solving', to ensure your application stands out to hiring managers.
How to prepare for a job interview at Vertex
✨Know Your Regulatory Guidelines
Familiarise yourself with the key regulatory guidelines such as FDA, EMA, and ICH. Be prepared to discuss how these regulations impact CMC submissions and your previous experiences in navigating them.
✨Showcase Your Interpersonal Skills
As a Regulatory CMC Manager, strong interpersonal skills are crucial. Prepare examples of how you've effectively communicated complex information to cross-functional teams and influenced decision-making.
✨Demonstrate Strategic Thinking
Be ready to discuss specific instances where you applied strategic thinking to solve complex problems in regulatory submissions or compliance issues. Highlight your ability to plan and prioritise effectively.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities in ambiguous situations. Think of examples from your past roles where you successfully navigated challenges related to CMC compliance.
