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- Tasks: Lead regulatory submissions for EU and ROW markets, ensuring compliance and documentation accuracy.
- Company: Join a biopharmaceutical company focused on innovative treatments for rare diseases.
- Benefits: Enjoy a 12-month contract with potential for extension and flexible work options.
- Why this job: Make a real impact in healthcare while working in a dynamic and supportive environment.
- Qualifications: Experience in regulatory affairs and knowledge of CMC requirements are essential.
- Other info: This role offers the chance to work on groundbreaking therapies.
The predicted salary is between 48000 - 72000 £ per year.
Regulatory Affairs Manager CMC biologicsYour new company
This biopharmaceutical company specialises in rare diseases and is looking for a Regulatory Affairs Manager CMC contractor. This is a 12-month contract job with scope for monthsYour new role
You will be responsible for EU and ROW markets, managing the authoring and compilation of all necessary CTD and regional administrative documentation fo…
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Regulatory Affairs Manager CMC biologics employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager CMC biologics
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements for CMC in biologics, especially for EU and ROW markets. This knowledge will help you demonstrate your expertise during discussions.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, particularly those who have experience in regulatory affairs. They can provide valuable insights and may even refer you to opportunities.
✨Tip Number 3
Stay updated on the latest trends and changes in regulations related to biologics. Being knowledgeable about current events can set you apart as a candidate who is proactive and informed.
✨Tip Number 4
Prepare to discuss specific examples from your past experience where you successfully managed regulatory submissions or navigated complex compliance issues. Real-life scenarios can showcase your problem-solving skills.
We think you need these skills to ace Regulatory Affairs Manager CMC biologics
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities of a Regulatory Affairs Manager CMC biologics. Familiarize yourself with the specific requirements for EU and ROW markets, as well as the CTD documentation process.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs, particularly in biologics and rare diseases. Emphasize your skills in authoring and compiling regulatory documents.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for biopharmaceuticals and your expertise in regulatory affairs. Mention specific projects or achievements that demonstrate your capability in managing CMC documentation.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no typos or grammatical errors, as attention to detail is crucial in regulatory affairs.
How to prepare for a job interview at Hays
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of the regulatory requirements for CMC in both EU and ROW markets. Familiarize yourself with the latest guidelines and how they apply to biologics, as this will demonstrate your expertise and readiness for the role.
✨Showcase Your Documentation Skills
Be prepared to discuss your experience with authoring and compiling CTD and regional administrative documentation. Highlight specific examples where your attention to detail and organizational skills made a difference in previous projects.
✨Emphasize Your Experience with Rare Diseases
Since the company specializes in rare diseases, it’s crucial to convey any relevant experience you have in this area. Discuss how your background aligns with their mission and how you can contribute to their goals.
✨Prepare Questions About the Company
Demonstrate your interest in the company by preparing thoughtful questions about their projects, culture, and future plans. This shows that you are not only focused on the role but also genuinely interested in being part of their team.
