At a Glance
- Tasks: Lead regulatory strategy for a high-profile late-stage small molecule asset.
- Company: Innovative global pharmaceutical organisation with a focus on patient impact.
- Benefits: Remote work, competitive pay, and the chance to shape global regulatory strategies.
- Other info: Opportunity to work with cross-functional teams and influence global market strategies.
- Why this job: Make a real difference in drug development and patient access through strategic leadership.
- Qualifications: 10+ years in Regulatory Affairs CMC with strong project leadership skills.
The predicted salary is between 63000 - 77000 £ per year.
- Senior Regulatory CMC Project Lead - Interim
- Late-Stage Small Molecule Development | Global Regulatory Strategy | MAA Preparation
- 6 months – renewable
- Remote
- If based in UK, Outside IR35
Are you a seasoned Regulatory CMC professional looking to take ownership of a high-profile late-stage asset approaching registration?
We're supporting an innovative global pharmaceutical organisation seeking a
Senior Regulatory CMC Project Lead to drive regulatory strategy for a key small molecule programme as it advances towards Marketing Authorisation submission.
This is a highly visible position where you'll play a central role in shaping global CMC regulatory strategy, influencing critical development decisions, and working alongside senior scientific, quality, supply chain and regulatory leaders across multiple geographies.
The Opportunity
You'll become the strategic Regulatory CMC lead for a late-stage small molecule asset, taking ownership of the global CMC regulatory roadmap and ensuring successful preparation and delivery of the registration dossier.
Working at the heart of a complex global development programme, you'll collaborate with cross-functional teams, lead agency interaction strategies, manage regulatory risk, and help accelerate the path to patients through innovative and pragmatic regulatory approaches.
This is an excellent opportunity for someone who enjoys combining technical CMC expertise with strategic leadership, stakeholder engagement, and regulatory project delivery.
What We're Looking For
- 10+ years' experience within Regulatory Affairs CMC – focused specifically on small molecule late stage development.
- Proven experience leading the CMC components of global Marketing Authorisation submissions.
- Strong understanding of late-stage development and registration activities for small molecule products.
- Experience developing and executing global regulatory strategies.
- Deep knowledge of FDA, EMA and ICH regulatory requirements.
- Exposure to international markets such as China, Japan, Brazil and Canada would be highly advantageous.
- Demonstrated success working within complex, cross-functional global development teams.
- Excellent project leadership, communication and stakeholder management skills.
- Strong analytical, problem-solving and risk management capabilities.
- Life Sciences degree required; MSc, Pharm D or Ph D preferred.
CMC, regulatory, MAA, late, phase, three, development, small, molecule, API, BLA, stage, interim, freelance, contract
Locations
Senior Regulatory CMC Project Lead in Hampshire, Portsmouth employer: RBW Consulting
Join a dynamic healthcare manufacturing site in Trefriw, North Wales, where you can make a significant impact as a Laboratory Supervisor. We offer a supportive and collaborative work culture that prioritises professional growth, with opportunities to lead a dedicated team and influence quality standards. Enjoy a competitive salary, career development prospects, and the chance to work in a beautiful location while contributing to meaningful advancements in laboratory science and compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory CMC Project Lead in Hampshire, Portsmouth
✨Network like a Pro
In the pharmaceutical industry, getting your foot in the door can often come down to who you know. So, connect with professionals through platforms like LinkedIn or attend industry-specific conferences and trade shows. These are golden opportunities to meet decision-makers and to showcase your expertise.
✨Show Off Your Expertise
As a freelancer, you really want to establish yourself as a go-to expert in your niche. Consider setting up a blog or contributing to pharmaceutical forums where you can share insights about trends and innovations. This will help increase your visibility and build credibility in the industry.
✨Join Freelance Platforms
Don't underestimate the power of freelance platforms that focus on the pharmaceutical sector. Websites like Upwork or industry-specific job boards can help you find gigs that match your skill set. Remember to tailor your profile to highlight your relevant experiences and credentials.
✨Leverage Your Local Networks
Since the pharmaceutical industry often hinges on relationships, reaching out to local universities or research institutions can lead to lead generation. They might have collaborations or projects looking for freelance talent. Plus, don’t forget to connect with local pharma associations for gigs and networking opportunities!
We think you need these skills to ace Senior Regulatory CMC Project Lead in Hampshire, Portsmouth
Some tips for your application 🫡
Showcase Your Expertise:In the pharmaceutical industry, it's super important to highlight your specific expertise. Make sure your CV or portfolio reflects your relevant experience—think clinical research, regulatory affairs, or drug development. Don’t forget to include any certifications or training you've completed that are particularly relevant to the role.
Include Case Studies or Project Samples:As a freelancer, your portfolio is your calling card. Include detailed case studies or samples from previous projects that highlight your contributions and results in the pharmaceutical sector. This could be anything from successful clinical trials you've worked on to regulatory submissions—use this to demonstrate your impact.
Articulate Your Availability and Rates:Freelance roles mean flexibility, so clarify your availability upfront. Be transparent about your rates too—this helps set the stage for negotiations. You can mention your preferred working hours and project lengths to align with what RBW Consulting might be looking for.
Tailor Your Cover Letter:Your cover letter should connect the dots between your experience and the needs of RBW Consulting. Use it to explain why you're interested in this freelance role specifically and how your background in the pharmaceutical industry can help solve their unique challenges. Let your personality shine through while remaining focused on professional achievements!
How to prepare for a job interview at RBW Consulting
✨Show Off Your Expertise
Freelancing in the pharmaceutical industry means you'll want to highlight your specialised knowledge. Make sure to showcase your experience with regulatory processes or clinical trials, as these are crucial in this field. Share specific projects you've worked on to demonstrate your capability!
✨Know Your Tools and Tech
If you've worked with any industry-specific software, like LabArchives or Empower, get ready to discuss your experience with them. Being familiar with these tools will set you apart during the interview, as they’re often central to project success in pharmaceuticals. Don’t forget to mention how you’ve used data analysis in your previous roles – it’s key in this sector!
✨Bring Your Portfolio to Life
As a freelancer, your portfolio is your calling card. Prepare a compelling presentation that outlines your previous projects, focusing on results and methodologies. Highlight any case studies or publications to show your contributions to research or development – this can really grab the attention of RBW Consulting.
✨Prepare for Scenario-Based Questions
Expect some scenario-based questions that might challenge your problem-solving skills in real-world contexts. Be ready to discuss how you would handle tight deadlines, regulatory hurdles, or unexpected findings in your projects. This will allow you to demonstrate not just your knowledge, but your practical abilities too!
