At a Glance
- Tasks: Lead regulatory strategy for drug substance in innovative biopharmaceutical projects.
- Company: Global biopharmaceutical organisation with a focus on cutting-edge drug development.
- Benefits: Remote work, competitive contract terms, and opportunities for ongoing engagement.
- Other info: Join a dynamic team working on high-profile global submissions.
- Why this job: Make a significant impact in the biopharmaceutical field with strategic leadership.
- Qualifications: Experience in Regulatory CMC and knowledge of drug substance development.
The predicted salary is between 59400 - 72600 £ per year.
Senior Regulatory CMC Consultant (Drug Substance/ ADC) 6-Month Contract (Renewable - ongoing) | Remote | Global Regulatory Strategy Are you a seasoned Regulatory CMC professional with deep expertise in drug substance development and a proven track record supporting global marketing authorisation submissions?
We are supporting an innovative global biopharmaceutical organisation seeking a Senior Regulatory CMC Consultant to provide strategic leadership for the regulatory drug substance activities associated with a high-profile development programme.
This role will have a particular focus on Antibody Drug Conjugates (ADCs), making prior ADC experience desirable but not essential.
The Opportunity As a senior member of the Regulatory CMC team, you will be responsible for defining and driving the global regulatory strategy for the drug substance component of the programme, working closely with cross-functional teams across Europe and the United States.
This is a highly visible position requiring both technical expertise and strategic regulatory leadership as the organisation prepares for key global submissions.
Key Responsibilities * Lead the Regulatory CMC strategy for the drug substance element of a complex biologics programme, with a particular focus on ADC linker-payload development. * Provide strategic guidance for upcoming global Marketing Authorisation Applications, including submissions to the FDA and EMA. * Act...
Senior Regulatory CMC Consultant (Drug Substance/ ADC) 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 Senior Regulatory CMC Consultant (Drug Substance/ ADC)
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like RBW Consulting.
We think you need these skills to ace Senior Regulatory CMC Consultant (Drug Substance/ ADC)
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at RBW Consulting.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at RBW Consulting. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at RBW Consulting
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with RBW Consulting.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help RBW Consulting achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
