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- Tasks: Lead global regulatory strategies for innovative pharmaceutical products and ensure compliance.
- Company: Join a leading pharmaceutical company with a focus on innovation and collaboration.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while working with cross-functional teams.
- Qualifications: Degree in life sciences and experience in regulatory submissions required.
- Other info: Dynamic role with potential for career advancement in a supportive environment.
The predicted salary is between 48000 - 72000 £ per year.
Type of Role: Contract position, Inside IR35
Location: Hybrid, 3 days on site in Paddington, London.
Department: Regulatory – Chemistry Manufacturing Controls
General Summary: The Manager, Regulatory Chemistry Manufacturing Controls 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 (SFDA, 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 and Experience:
- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field.
- Experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience.
Seniority Level: Mid-Senior level
Employment Type: Contract
Job Function: Other
Industries: Pharmaceutical Manufacturing
Manager, Regulatory CMC employer: Vertex Pharmaceuticals
Contact Detail:
Vertex Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Regulatory CMC
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the hunt for a Manager, Regulatory CMC role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of regulatory guidelines like SFDA, EMA, and ICH. We want you to be able to discuss how your experience aligns with the role and how you can contribute to global regulatory CMC strategies.
✨Tip Number 3
Showcase your problem-solving skills! Be ready to share examples of how you've tackled complex situations in previous roles. This will demonstrate your strategic thinking and ability to influence regulatory assessments.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Manager, Regulatory CMC
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Manager, Regulatory CMC. Highlight your experience with regulatory submissions and any relevant skills that match the job description. We want to see how you can influence global regulatory strategies!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that demonstrate your strategic thinking and problem-solving skills, as these are key for us.
Showcase Your Interpersonal Skills: Since this role involves collaboration with cross-functional teams, make sure to highlight your strong interpersonal skills in your application. We love candidates who can communicate complex information clearly and effectively!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Vertex Pharmaceuticals
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of Chemistry Manufacturing Controls (CMC) regulations. Familiarise yourself with the specific guidelines from SFDA, EMA, and ICH, as well as any recent changes. This will not only help you answer questions confidently but also show that you're proactive and well-prepared.
✨Showcase Your Interpersonal Skills
Since this role requires strong interpersonal skills, think of examples where you've successfully communicated complex information or guided teams through regulatory processes. Be ready to discuss how you’ve influenced cross-functional teams in the past, as this will demonstrate your ability to collaborate effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your strategic thinking and problem-solving abilities. Prepare for scenario-based questions where you might need to resolve complex situations related to compliance or change controls. Practising these scenarios can help you articulate your thought process clearly during the interview.
✨Plan Your Questions
Interviews are a two-way street, so prepare insightful questions about the company's regulatory strategies and team dynamics. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values. Plus, it gives you a chance to engage with the interviewers on a deeper level.
