At a Glance
- Tasks: Manage CMC dossier trackers and coordinate regulatory submission processes.
- Company: Join a growing global pharmaceutical organisation with a collaborative spirit.
- Benefits: Competitive salary, flexible working hours, and opportunities for professional growth.
- Other info: Dynamic work environment with excellent career advancement opportunities.
- Why this job: Make a real impact in the pharmaceutical industry while developing your project management skills.
- Qualifications: 3+ years in CMC or regulatory project management; degree in a scientific field.
The predicted salary is between 51750 - 63250 £ per year.
RBW Consulting are partnered with a growing medium sized global Pharmaceutical organisation in their search for a Dossier Delivery Regulatory CMC Project Manager.
We are seeking an experienced
CMC Regulatory Project Manager to support the tracking, review, and approval of CMC submission documents for global regulatory filings.
Key Responsibilities
- Manage CMC dossier trackers, timelines, and document status updates.
- Coordinate review, approval, and comment resolution processes with technical and regulatory stakeholders.
- Lead tracking meetings and provide progress updates to project teams and submission managers.
- Oversee document management within
Veeva Regulatory Vault .
- Ensure documentation is collected, reviewed, and delivered to agreed deadlines.
- Support the preparation and delivery of regulatory response dossiers.
Requirements
- 3+ years' experience in a CMC, regulatory, or project coordination/management environment.
- Experience managing projects within a CMC setting.
- Understanding of NDA/MAA submissions and CTD structure.
- Knowledge of drug manufacturing and control processes.
- Degree in a scientific or technical discipline.
- Strong working knowledge of Excel, Power Point, Share Point, databases, and document management systems (Veeva Vault preferred).
- Fluent English
- Able to work within EU/UK or US East Coast time zones.
Key Skills
- Highly organised with strong attention to detail.
- Comfortable managing multiple priorities simultaneously.
- Excellent communication and stakeholder management skills.
Please apply here and RBW Consulting will be in touch on the next steps.
Regulatory CMC Project Manager in Basingstoke employer: RBW Consulting
RBW Consulting is an excellent employer, offering a dynamic work environment in West Cheshire that fosters innovation and collaboration. Employees benefit from a strong focus on professional development, with opportunities for growth and skill enhancement in the fast-paced engineering sector. The company values its team members, providing a supportive culture that encourages work-life balance and rewards dedication.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory CMC Project Manager in Basingstoke
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We think you need these skills to ace Regulatory CMC Project Manager in Basingstoke
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at RBW Consulting!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show RBW Consulting that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at RBW Consulting!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At RBW Consulting, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at RBW Consulting
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at RBW Consulting that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with RBW Consulting’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
