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- Tasks: Manage regulatory submissions for biologics in EU and ROW markets.
- Company: Join a biopharmaceutical company focused on rare diseases.
- Benefits: 12-month contract with potential for extension.
- Why this job: Be part of a team ensuring high-quality drug development and compliance.
- Qualifications: Experience in biologics is essential for this role.
- Other info: Collaborate with global teams to drive impactful regulatory processes.
The predicted salary is between 43200 - 72000 £ per year.
Regulatory Affairs Manager CMC biologics Your 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 months Your new role You will be responsible for EU and ROW markets, managing the authoring and compilation of all necessary CTD and regional administrative documentation for CMC-related worldwide regulatory submissions, through direct liaison with globally located Regulatory and Technical Operations team members. Ensure submissions are high quality, and that the content and format of regulatory submissions comply with regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics. What you’ll need to succeed In order to be considered for this contract job as Regulatory Affairs Manager in the CMC team, you must have experience working in biologics. Unfortunately, without these applications, it won’t be considered. What you need to do now For more information on this or any other Regulatory Affairs biological CMC contract jobs, please apply to this advert JBRP1_UKTJ
Hays | Regulatory Affairs Manager CMC biologics employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Hays | Regulatory Affairs Manager CMC biologics
✨Tip Number 1
Make sure to highlight your experience in biologics during any networking opportunities. Connect with professionals in the field through LinkedIn or industry events to discuss your background and express your interest in the Regulatory Affairs Manager position.
✨Tip Number 2
Familiarize yourself with the latest regulations and guidelines governing CMC submissions for biologics. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Consider reaching out to current or former employees of the company to gain insights into their work culture and expectations for the Regulatory Affairs Manager role. This can provide you with valuable information to tailor your approach.
✨Tip Number 4
Prepare specific examples from your past experiences that showcase your ability to manage high-quality regulatory submissions. Being able to discuss these examples confidently can set you apart during interviews.
We think you need these skills to ace Hays | 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 and expectations outlined in the job description.
Highlight Relevant Experience: Emphasize your experience in biologics and any previous roles related to regulatory affairs. Use specific examples to demonstrate your expertise in managing CTD and regulatory submissions.
Tailor Your CV: Customize your CV to align with the job description. Focus on relevant skills, achievements, and experiences that showcase your ability to meet the demands of the role.
Craft a Strong Cover Letter: Write a compelling cover letter that explains why you are the perfect fit for this position. Address your understanding of the regulatory landscape and your commitment to high-quality submissions.
How to prepare for a job interview at Hays
✨Showcase Your Biologics Experience
Make sure to highlight your specific experience in biologics during the interview. Prepare examples of past projects where you managed regulatory submissions, focusing on your role and the impact of your work.
✨Understand Regulatory Guidelines
Familiarize yourself with the latest EU and ROW regulatory guidelines related to CMC for biologics. Being able to discuss these regulations confidently will demonstrate your expertise and preparedness for the role.
✨Emphasize Collaboration Skills
Since the role involves liaising with globally located teams, be ready to discuss your experience working in cross-functional teams. Share examples that showcase your communication skills and ability to collaborate effectively.
✨Prepare for Technical Questions
Expect technical questions related to CTD documentation and regulatory submission processes. Brush up on your knowledge and be prepared to explain how you ensure high-quality submissions that comply with regulations.
