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For Companies At a Glance
- Tasks: Manage regulatory submissions and ensure compliance for clinical trials and medicinal products.
- Company: Join Amgen, a leading biopharmaceutical company in a collaborative environment.
- Benefits: Enjoy growth opportunities, a generous rewards plan, and work/life balance.
- Why this job: Make a real impact in the healthcare industry while advancing your career.
- Qualifications: Scientific degree and experience in regulatory affairs required.
- Other info: Flexible work-from-home options with a diverse and inclusive community.
The predicted salary is between 36000 - 60000 £ per year.
In this vital role you will work to ensure Amgen acquires and maintains all the required licenses to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. You will support one or more products from a regional regulatory perspective.
Responsibilities
- Plan and manage regulatory submissions (e.g., clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
- Implement product‑related regulatory strategies, regulatory affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.
- Provide regulatory guidance on regional regulatory mechanisms to optimise product development (e.g., expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans).
- Support regional label negotiation activities.
- Participate in the development and execution of regional regulatory product strategies.
- Develop predictions for expectations and risks associated with outcomes by regulatory agencies.
- Maintain awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products.
- Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.
Qualifications
- Scientific degree and demonstrated experience in a similar role.
- Knowledge of regulatory principles, policies, procedures and SOPs.
- Knowledge of legislation and regulations relating to medicinal products.
- Awareness of registration procedures in the region for clinical trials, MA, post‑approval changes, extensions and renewals.
- Knowledge of drug development and regional regulatory environment.
- Strong communication skills – both oral and written.
- Ability to understand and communicate scientific/clinical information.
- Ability to anticipate and prevent potential issues.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
Benefits
- Growth opportunities to learn and move up and across our global organisation.
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
- Generous total rewards plan comprising health, finance and wealth, work/life balance and career benefits.
Location & Work Hours
Flexibility to work from home with occasional visits to our Cambridge or Uxbridge office.
Regulatory Affairs Manager in Cambridge employer: WRITEMAN
Contact Detail:
WRITEMAN Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Cambridge
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs field, especially those at Amgen or similar companies. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory principles and recent changes in legislation. We want you to shine when discussing how you can contribute to Amgen's goals!
✨Tip Number 3
Showcase your communication skills! Whether it's during an interview or networking event, be ready to explain complex regulatory concepts in simple terms. This will demonstrate your ability to bridge the gap between science and regulation.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're serious about joining our team at Amgen.
We think you need these skills to ace Regulatory Affairs Manager in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your relevant experience and skills that match the job description, especially your knowledge of regulatory principles and drug development.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a perfect fit for Amgen. Don’t forget to mention any specific projects or achievements that relate to the role.
Showcase Your Communication Skills: Since strong communication skills are key for this role, make sure your application reflects that. Use clear and concise language, and don’t shy away from demonstrating your ability to convey complex information effectively.
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It’s straightforward and ensures your application goes directly to us, so we can review it promptly!
How to prepare for a job interview at WRITEMAN
✨Know Your Regulations
Make sure you brush up on the latest regulations and guidelines related to medicinal products. Familiarise yourself with Amgen's portfolio and understand how regional regulations impact their products. This will show your commitment and expertise during the interview.
✨Prepare for Scenario Questions
Expect questions that ask you to solve hypothetical regulatory challenges. Think about past experiences where you navigated complex regulatory environments and be ready to discuss your thought process and outcomes. This will demonstrate your problem-solving skills and ability to anticipate issues.
✨Showcase Your Communication Skills
As a Regulatory Affairs Manager, strong communication is key. Prepare to articulate complex scientific and regulatory information clearly. Practice explaining technical concepts in simple terms, as this will highlight your ability to communicate effectively with diverse stakeholders.
✨Research Amgen’s Culture
Understand Amgen's values and culture, especially their commitment to diversity and inclusion. Be ready to discuss how your personal values align with theirs and how you can contribute to their community. This will help you stand out as a candidate who fits well within their team.
