Global CMC Regulatory Science Lead (International)

Global CMC Regulatory Science Lead (International)

Full-Time 80000 - 100000 £ / year (est.) No working from home possible
Moderna

At a Glance

  • Tasks: Lead regulatory strategies and ensure compliance for innovative pharmaceutical products.
  • Company: Join Moderna, a leader in biotechnology and health innovation.
  • Benefits: Best-in-class healthcare, extensive paid time off, and a focus on employee well-being.
  • Other info: Opportunity to work in a dynamic environment with a commitment to innovation.
  • Why this job: Make a significant impact in the pharmaceutical industry with your expertise.
  • Qualifications: MS/PhD in a relevant field and 10+ years in Regulatory CMC for Biologics.

The predicted salary is between 80000 - 100000 £ per year.

Moderna is seeking an Associate Director, CMC Regulatory Science-International to oversee CMC and Quality related agency correspondence and regulatory applications. You will be responsible for developing regulatory strategies for multiple products while ensuring compliance with health authority guidelines.

The ideal candidate will have a MS/PhD in a relevant field, 10+ years in the pharmaceutical industry and specific experience in Regulatory CMC for Biologics.

This role offers best-in-class healthcare, extensive paid time off and a commitment to employee well-being.

Global CMC Regulatory Science Lead (International) employer: Moderna

Moderna is an exceptional employer that prioritises employee well-being and professional growth, offering best-in-class healthcare and extensive paid time off. With a collaborative work culture that fosters innovation and supports career advancement, employees are empowered to make a meaningful impact in the pharmaceutical industry while working in a dynamic international environment.

Moderna

Contact Details:

Moderna Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Global CMC Regulatory Science Lead (International)

Tip Number 1

Network like a pro! Reach out to professionals in the pharmaceutical industry, especially those with experience in CMC Regulatory Science. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!

Tip Number 2

Prepare for interviews by brushing up on your knowledge of regulatory guidelines and compliance. We recommend creating a list of common interview questions related to CMC and practising your responses. Confidence is key, so let your expertise shine!

Tip Number 3

Showcase your passion for the industry! During interviews, share specific examples of how you've navigated complex regulatory challenges in the past. This will demonstrate your problem-solving skills and commitment to compliance.

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 take the initiative to engage directly with us. Let’s get you that Global CMC Regulatory Science Lead role!

We think you need these skills to ace Global CMC Regulatory Science Lead (International)

Regulatory CMC Expertise
Pharmaceutical Industry Knowledge
Biologics Experience
Regulatory Strategy Development
Agency Correspondence Management
Quality Compliance
Health Authority Guidelines Familiarity

Some tips for your application 🫡

Tailor Your CV:Make sure your CV is tailored to highlight your experience in CMC and Regulatory Science. We want to see how your background aligns with the role, so don’t be shy about showcasing your relevant skills and achievements!

Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role at Moderna and how your expertise can contribute to our mission. Keep it engaging and personal – we love to see your personality come through.

Showcase Your Experience:When detailing your experience, focus on specific projects or roles that demonstrate your knowledge in CMC for Biologics. We’re looking for concrete examples of how you’ve navigated regulatory challenges and contributed to successful outcomes.

Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts and you’ll be all set!

How to prepare for a job interview at Moderna

Know Your CMC Inside Out

Make sure you brush up on your knowledge of Chemistry, Manufacturing, and Controls (CMC) regulations. Familiarise yourself with the latest guidelines from health authorities, especially those relevant to biologics. This will not only help you answer technical questions but also show your passion for the field.

Showcase Your Experience

With 10+ years in the pharmaceutical industry, you’ve got a wealth of experience. Prepare specific examples of how you've developed regulatory strategies or handled agency correspondence. Use the STAR method (Situation, Task, Action, Result) to structure your responses and make them impactful.

Understand Moderna's Mission

Research Moderna’s products and their impact on global health. Be ready to discuss how your role as a Global CMC Regulatory Science Lead aligns with their mission. This shows that you’re not just looking for any job, but that you genuinely want to contribute to their goals.

Prepare Questions for Them

Interviews are a two-way street! Prepare thoughtful questions about the team dynamics, challenges they face in regulatory compliance, or how they measure success in this role. This demonstrates your interest and helps you assess if the company is the right fit for you.