Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Join us as a Regulatory Affairs Consultant, managing CMC components for drug applications.
- Company: Parexel Consulting is a leader in the pharmaceutical industry, driving innovation and success.
- Benefits: Enjoy a hybrid work model and collaborate with top-tier professionals in a dynamic environment.
- Why this job: This role offers exposure to cutting-edge technologies and impactful projects in healthcare.
- Qualifications: You need a scientific degree and 3-5 years of relevant regulatory experience.
- Other info: Fluency in English is essential; previous experience with small molecules is a plus.
The predicted salary is between 36000 - 60000 £ per year.
Job Title: Regulatory Affairs Consultant – CMC small molecule
Job Location: London, UK
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Parexel Consulting is seeking a talented and experienced CMC Regulatory Affairs Professional to join our team as a Regulatory Affairs Consultant. In this role, you will have the opportunity to utilize your expertise in CMC, exceptional communication skills, and strong writing experience, contributing to our clients’ success in the pharmaceutical industry. This position offers exposure to novel technologies and a wide range of responsibilities, from clinical trials to post-approval and maintenance.
As the Regulatory Affairs Consultant, you will collaborate closely with a multinational pharmaceutical company, ensuring the effective planning, review, and preparation of CMC components for investigational new drugs, new drug license applications, progress reports, amendments, supplemental applications, and maintenance of approved marketed products.
Your Key Responsibilities Will Include:
- Assisting in the technical review and preparation of investigational drug applications, marketing applications, and other reports for submission to regulatory agencies.
- Ensuring that documents meet established regulatory requirements in terms of content and structure.
- Serving as a liaison between various functional groups, program teams, international regulatory bodies, and business partners, proposing solutions based on your technical experience and identifying potential project timeline delays.
- Maintaining Regulatory CMC documentation.
- Managing related databases and submission schedules.
- Assisting in the development of submission plans and project timelines.
- Preparing for and interacting with regulatory agencies during drug submissions, responding to inquiries, and participating in regulatory agency inspections.
Skills And Experience Required For The Role:
- University degree in a scientific field.
- 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority.
- Successful experience in delivering CMC sections of marketing authorizations, investigational drugs, and life cycle management of commercial products.
- Knowledge of EMA guidance, regulations, and ICH/GMP requirements.
- Previous regulatory experience with small molecules.
- Experience with EU submissions via the Centralised Procedure and national procedures.
- Experience with extension applications for new strengths and/or pharmaceutical dosage forms.
- Experience supporting the preparation of CMC documentation for IMPDs and new product EU MAAs would be advantageous.
- Ability to work independently and within project teams or committees, demonstrating accountability in achieving group goals and key project milestones.
- Fluent in English written and spoken.
#J-18808-Ljbffr
Regulatory Affairs Consultant - CMC small molecule employer: Lifelancer
Contact Detail:
Lifelancer Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant - CMC small molecule
✨Tip Number 1
Make sure to network with professionals in the pharmaceutical industry, especially those who have experience in CMC regulatory affairs. Attend industry conferences or webinars where you can meet potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Familiarize yourself with the specific regulations and guidelines from the EMA and ICH that pertain to small molecules. 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 Parexel Consulting on platforms like LinkedIn. They can provide insights into the company culture and the specific expectations for the Regulatory Affairs Consultant role.
✨Tip Number 4
Prepare for potential interview questions by practicing how you would handle specific scenarios related to CMC documentation and regulatory submissions. Being able to articulate your thought process and problem-solving skills will set you apart from other candidates.
We think you need these skills to ace Regulatory Affairs Consultant - CMC small molecule
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Regulatory Affairs Consultant position. Understand the key responsibilities and required skills, especially focusing on CMC components and regulatory requirements.
Tailor Your CV: Customize your CV to highlight relevant experience in CMC regulatory affairs, particularly your work with small molecules and any previous roles in the pharmaceutical industry. Make sure to emphasize your communication skills and writing experience.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for regulatory affairs and your understanding of the pharmaceutical industry. Mention specific experiences that align with the responsibilities listed in the job description.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your writing is clear and professional, as strong writing skills are essential for this role.
How to prepare for a job interview at Lifelancer
✨Showcase Your CMC Expertise
Be prepared to discuss your specific experience with CMC regulatory affairs, especially regarding small molecules. Highlight any successful submissions you've managed and how you ensured compliance with EMA guidance and ICH/GMP requirements.
✨Demonstrate Strong Communication Skills
Since the role involves liaising with various teams and regulatory bodies, practice articulating complex regulatory concepts clearly and concisely. Use examples from your past experiences to illustrate your communication effectiveness.
✨Prepare for Technical Questions
Expect questions related to the technical aspects of CMC documentation and regulatory submissions. Brush up on your knowledge of investigational drug applications and marketing authorizations to confidently answer these queries.
✨Discuss Project Management Experience
Share examples of how you've managed project timelines and submission schedules in previous roles. Emphasize your ability to identify potential delays and propose effective solutions, showcasing your problem-solving skills.
