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- Tasks: Lead the preparation of CMC documents for global regulatory submissions.
- Company: Join a dynamic global biopharma company making a difference in healthcare.
- Benefits: Enjoy a 12-month contract with opportunities for professional growth and development.
- Why this job: Be part of a collaborative team impacting international markets and enhancing patient care.
- Qualifications: Significant experience in regulatory affairs and knowledge of ICH and regional requirements needed.
- Other info: Work permit required for non-passport holders; apply through the 'Apply now' button.
The predicted salary is between 28800 - 48000 £ per year.
My client is a global biopharma company. They are seeking a Regulatory Affairs Manager (CMC) to join our Regulatory Affairs Team based in Cambridge on a 12 month contract.
Key Responsibilities
- Co-ordinate the preparation of high quality CMC documents to support regulatory submissions in International regions, (Asia, Latin America, Middle East, Eastern Europe and Africa)
- Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals
- Co-ordinate the preparation of responses to CMC questions from regulatory authorities
- Maintain an up-to-date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner
Knowledge, Experience and Skills
- Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
- Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
- Well versed and competent with regulatory documentation and submission management systems
- Excellent verbal, written and interpersonal communication skills are required
- Must have excellent organizational skills and an ability to work on a number of projects with tight timelines.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the 'Apply now' button.
Regulatory Affairs Manager - CMC employer: Parkside
Contact Detail:
Parkside Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager - CMC
✨Tip Number 1
Familiarise yourself with the specific CMC regulatory requirements for the regions mentioned in the job description. This knowledge will not only help you stand out during interviews but also demonstrate your proactive approach to understanding the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in CMC. Attend industry events or join relevant online forums to gain insights and potentially get referrals that could boost your application.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in managing CMC submissions and how you navigated challenges. This will showcase your expertise and problem-solving skills, which are crucial for this role.
✨Tip Number 4
Stay updated on the latest trends and changes in regulatory affairs, particularly those affecting biopharma. Being knowledgeable about current events can give you an edge in discussions and show your commitment to the field.
We think you need these skills to ace Regulatory Affairs Manager - CMC
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Affairs Manager (CMC). Familiarise yourself with CMC documentation and regulatory requirements specific to the regions mentioned in the job description.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, especially any work related to CMC submissions. Use specific examples that demonstrate your knowledge of ICH requirements and your ability to manage multiple projects under tight deadlines.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the biopharma industry. Mention how your skills align with the key responsibilities outlined in the job description, particularly your experience with regulatory documentation and submission management systems.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or typos. Ensure that your communication is clear and professional, as excellent written communication skills are essential for this role.
How to prepare for a job interview at Parkside
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of ICH requirements and regional regulations during the interview. Be prepared to discuss specific examples from your past experience that demonstrate your expertise in preparing CMC regulatory dossiers.
✨Demonstrate Strong Communication Skills
Since excellent verbal and written communication skills are crucial for this role, practice articulating your thoughts clearly. You might be asked to explain complex regulatory concepts, so ensure you can do this in a straightforward manner.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world situations. Think of scenarios where you had to coordinate with multiple teams or respond to regulatory queries, and be ready to explain your approach and outcomes.
✨Stay Updated on Regulatory Changes
Research recent changes in CMC regulations relevant to the regions mentioned in the job description. Showing that you are proactive about staying informed will demonstrate your commitment to the role and the company.
