Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory activities for a small molecule oncology product globally.
- Company: Join an international pharmaceutical company focused on innovative product development.
- Benefits: Contract role with potential extension and opportunities for professional growth.
- Why this job: Make a real impact in oncology while collaborating with global teams.
- Qualifications: 10+ years in CMC roles, with 5+ years in lifecycle management of small molecules.
- Other info: Proficiency in English required; French is a plus.
The predicted salary is between 48000 - 72000 £ per year.
Regulatory CMC Project Manager – Contract Partnering with an international pharmaceutical company focused on both in house product development and CDMO services, we are now supporting the appointment of a new Regulatory CMC Project Manager to oversee regulatory activities for a small molecule oncology product globally. This position will be a contract until the end of March 2025, with strong likelihood of extension for a further 6 month period. This role involves working independently and with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities. Key responsibilities: Change control procedures Out of specification management CMC commitments and variation submissions Product Quality Review (PQR) production and review Collaboration with external CMOs Manage CMC regulatory activities for clinical programs, including: Authoring INDs and IMPDs Responding to Health Authorities Preparing documents for QP release Post-submission management Key Experience: Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products Experience in pre- and post-approval CMC regulatory activities Effective stakeholder management Project management within a CMC context Knowledge of IND/NDA and IMPD/MAA formats Understanding of drug substance and product CMC Organized, independent, and able to manage multiple activities Degree in Pharmacy or a relevant science/technical subject Language skills: Proficient in English, French is an advantage Regulatory, CMC, project, manager, small, molecule, IND, IMPD, PQR, change, control, quality, assurance, RA, affairs, submission, oncology, cancer, therapy, MAA, marketing, authorisation
Regulatory CMC Project Manager employer: RBW Consulting
Contact Detail:
RBW Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory CMC Project Manager
✨Tip Number 1
Make sure to highlight your extensive experience in CMC technical roles, especially your work with small molecule products. This will show that you have the necessary background for the responsibilities outlined in the job description.
✨Tip Number 2
Demonstrate your project management skills by discussing specific examples where you've successfully managed multiple CMC activities. This will help illustrate your ability to handle the independent nature of the role.
✨Tip Number 3
Familiarize yourself with the regulatory landscape, particularly IND/NDA and IMPD/MAA formats. Being well-versed in these areas will give you an edge during discussions with our team.
✨Tip Number 4
If you have proficiency in French, make sure to mention it! This could be a valuable asset in collaborating with international stakeholders and may set you apart from other candidates.
We think you need these skills to ace Regulatory CMC Project Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory CMC Project Manager position. Highlight key responsibilities and required experiences that align with your background.
Tailor Your CV: Customize your CV to emphasize your relevant experience in CMC technical roles, particularly in small molecule products. Include specific examples of your work with change controls, out of specification management, and regulatory submissions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the role and your passion for oncology product development. Mention your proficiency in English and any additional language skills, like French, that could be beneficial.
Highlight Key Achievements: In both your CV and cover letter, include quantifiable achievements from your previous roles. This could be successful project completions, improvements in processes, or effective stakeholder management that demonstrate your capability as a project manager.
How to prepare for a job interview at RBW Consulting
✨Showcase Your CMC Expertise
Make sure to highlight your extensive experience in CMC technical roles, especially your work with small molecule products. Be prepared to discuss specific projects where you managed lifecycle activities and how you navigated regulatory challenges.
✨Demonstrate Stakeholder Management Skills
Since effective stakeholder management is crucial for this role, come ready with examples of how you've successfully collaborated with various teams and external partners. Discuss any strategies you used to ensure clear communication and alignment on project goals.
✨Prepare for Regulatory Questions
Brush up on your knowledge of IND/NDA and IMPD/MAA formats, as well as change control procedures. Expect questions that assess your understanding of regulatory requirements and how you've applied them in past roles.
✨Exhibit Organizational Skills
This position requires managing multiple activities independently. Be ready to share how you prioritize tasks and stay organized under pressure. Consider discussing tools or methods you use to keep track of your projects and deadlines.
