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- Tasks: Provide strategic regulatory advice and lead complex projects in the healthcare sector.
- Company: Rapidly growing international regulatory consulting organisation focused on healthcare innovation.
- Benefits: Remote work, leadership opportunities, and a chance to influence global healthcare.
- Other info: Flexible remote work with monthly office meetings and excellent career growth potential.
- Why this job: Make a real impact in advancing healthcare while mentoring future leaders.
- Qualifications: Advanced degree in a science-related field and extensive experience in regulatory affairs.
The predicted salary is between 70000 - 90000 £ per year.
This role is with a rapidly growing international regulatory consulting organization focused on advancing healthcare innovation through expert scientific and regulatory support. The company partners with clients to streamline product development, reduce time-to-market, and deliver strategic solutions across global markets. As a Principal or Senior Regulatory Affairs CMC Consultant, you will play a key leadership role, providing high-level regulatory and technical guidance for complex therapeutics. The position offers opportunities to mentor team members, influence business growth, and engage directly with global regulatory authorities. This role can be remotely based across the United Kingdom with a once-a-month in office requirement.
Responsibilities
- Provide strategic, technical, and regulatory CMC advice to clients, supporting the development of human medicinal products.
- Develop innovative drug development plans, data gap analyses, and global regulatory strategies for complex products.
- Author, review, and contribute to key regulatory documents, including development plans, clinical trial applications, and marketing authorizations.
- Lead multi-jurisdictional projects, ensuring delivery within timelines and budget while maintaining high-quality standards.
- Represent clients in interactions with regulatory agencies and provide solutions to regulatory challenges and objections.
- Lead, mentor, and manage team members while supporting business development initiatives and client relationship growth.
Requirements
- Bachelor’s degree in a science-related field, with an advanced degree (MSc or preferably PhD) in a biomedical or related discipline.
- Principal level - minimum of 10 years’ experience in CMC development, regulatory strategy, and compliance within the pharmaceutical or biotech industry. Senior level - minimum of 5 years experience.
- Strong knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.
- Proven experience managing regulatory submissions across MAA/BLA and interactions with agencies such as FDA, MHRA, EMA, or TGA.
- Experience working on biologics programs is preferred.
- Demonstrated ability to lead teams, mentor staff, and deliver strategic consultancy services to clients.
- Excellent communication, organizational, and problem-solving skills, with flexibility to travel and work across international teams.
If you are interested in learning more, apply to this job post and reach out to Amit at .
Principal/Senior Regulatory Affairs CMC Consultant in Milton Keynes employer: Meet Life Sciences
Contact Detail:
Meet Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal/Senior Regulatory Affairs CMC Consultant in Milton Keynes
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory requirements. Be ready to discuss how your experience aligns with the role, especially around CMC development and regulatory strategy.
✨Tip Number 3
Showcase your leadership skills! If you've mentored team members or led projects, be sure to highlight these experiences during interviews. Companies love candidates who can inspire and guide others.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you're serious about joining our team and contributing to healthcare innovation.
We think you need these skills to ace Principal/Senior Regulatory Affairs CMC Consultant in Milton Keynes
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the job description. Highlight your regulatory affairs experience, especially in CMC development, to show us you’re the right fit for this role.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you’re passionate about regulatory affairs and how your background aligns with our mission. Share specific examples of your achievements in leading projects or mentoring teams to grab our attention.
Showcase Your Leadership Skills: Since this role involves mentoring and leading teams, make sure to highlight any relevant leadership experiences. We want to see how you've influenced business growth and supported team members in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother application process. This way, we can easily track your application and get back to you quicker!
How to prepare for a job interview at Meet Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on global regulatory requirements, especially FDA, EMA, and ICH guidelines. Be ready to discuss your experience with regulatory submissions and how you've navigated challenges in the past.
✨Showcase Your Leadership Skills
As a Principal or Senior Consultant, you'll be expected to lead and mentor. Prepare examples of how you've successfully managed teams and contributed to business growth. Highlight any specific projects where your leadership made a difference.
✨Prepare for Technical Questions
Expect to dive deep into CMC development and regulatory strategy. Review key concepts and be ready to discuss innovative drug development plans or data gap analyses you've worked on. This is your chance to shine!
✨Engage with Real-World Scenarios
Think about potential regulatory challenges that could arise in your role. Be prepared to discuss how you would approach these situations and provide solutions. This shows your problem-solving skills and strategic thinking.