At a Glance
- Tasks: Lead regulatory CMC strategy and submission planning for innovative therapies.
- Company: Join a pioneering late-stage biotechnology company making a real difference.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with significant visibility and influence.
- Why this job: Be at the forefront of transformative medicine and global regulatory submissions.
- Qualifications: Experience in regulatory CMC and knowledge of NDA/MAA submissions required.
The predicted salary is between 60000 - 80000 £ per year.
Allerton Bishop is delighted to be partnering with an innovative late-stage biotechnology company to appoint a Senior Regulatory CMC Project Manager on a 12-month contract. This is a rare opportunity to play a pivotal role in the development and registration of a novel therapy that is progressing through late-stage clinical development and approaching global regulatory submission.
Working directly with the Vice President of Regulatory Affairs and senior CMC leadership, the successful candidate will lead Regulatory CMC strategy, submission planning, and cross-functional programme execution to support NDA and MAA filings across major global markets. This position offers significant visibility and influence within a highly collaborative biotechnology environment, providing the opportunity to contribute directly to the successful registration and commercialisation of a potentially transformative medicine.
The Opportunity
As Senior Regulatory CMC Project Manager, you will act as the critical interface between Regulatory Affairs, CMC Development, Technical Operations, Quality, Supply Chain, and external manufacturing partners. You will be responsible for driving CMC regulatory activities associated with late-stage development and commercial readiness, ensuring alignment between technical development programmes and global regulatory expectations. A key focus of the role will be supporting the preparation, review, and authoring of CMC documentation required for NDA and MAA submissions.
Key Responsibilities
- Regulatory CMC Leadership: Lead Regulatory CMC activities supporting late phase development and registration strategy. Develop and execute global CMC regulatory plans aligned to submission timelines. Act as the primary Regulatory CMC representative across cross-functional project teams. Provide strategic guidance on manufacturing changes, process validation, analytical methods, comparability, stability and lifecycle management activities. Assess regulatory risks associated with technical and operational decisions.
- NDA & MAA Submission Activities: Lead preparation, review and authoring of Module 3 documentation for global submissions. Support NDA, MAA, IND, CTA and lifecycle management activities. Coordinate technical contributions from internal stakeholders, CDMOs and external consultants. Ensure consistency and compliance across all CMC submission documents and responses to Health Authority questions and deficiency requests.
- Global Regulatory Strategy: Support interactions with FDA, EMA and other international regulatory authorities. Provide guidance on evolving regulatory expectations and industry best practice. Partner with senior leadership to ensure regulatory strategies support accelerated development and commercial objectives. Contribute to inspection readiness and commercial launch planning activities.
- Programme Leadership: Drive complex cross-functional CMC deliverables and regulatory milestones. Coordinate internal and external stakeholders to ensure timely execution of submission activities. Support programme governance, timeline management and critical path planning. Manage relationships with CDMOs, consultants and development partners.
Candidate Profile
We are seeking experienced Regulatory CMC professionals with proven expertise supporting late-stage development and commercial registration programmes. Successful candidates are likely to bring experience from biotechnology research, pharmaceutical manufacturers or regulatory consultancy.
Essential Experience:
- Significant Regulatory CMC experience supporting small molecule pharmaceutical products.
- Demonstrable experience authoring and reviewing Module 3 documents involved in NDA and/or MAA submissions.
- Experience supporting products through late phase development and registration activities.
- Strong understanding of global CMC regulatory requirements including FDA, EMA and ICH guidance.
- Experience leading or supporting successful NDA approvals.
Senior Regulatory Project Manager in Portsmouth employer: Allerton Bishop Search
Join a pioneering late-stage biotechnology company that values innovation and collaboration, offering a unique opportunity to lead critical regulatory CMC activities in a remote role based in the UK. With a strong focus on employee growth and development, this organisation fosters a supportive work culture where your contributions directly impact the successful registration and commercialisation of transformative therapies. Enjoy the flexibility of remote work while being part of a dynamic team dedicated to advancing healthcare solutions globally.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Project Manager in Portsmouth
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech industry, especially those who have experience with regulatory affairs. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory requirements. Be ready to discuss your experience with NDA and MAA submissions, as well as how you’ve navigated complex CMC challenges in the past.
✨Tip Number 3
Showcase your leadership skills! In interviews, highlight instances where you’ve successfully led cross-functional teams or managed relationships with external partners. This will demonstrate your ability to drive CMC deliverables.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Regulatory Project Manager in Portsmouth
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in Regulatory CMC. Use keywords from the job description to show that you understand what we're looking for.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past experiences that align with the responsibilities mentioned in the job description.
Showcase Your Achievements:Don’t just list your duties; showcase your achievements in previous roles. Quantify your successes where possible, as this helps us see the impact you've made in your past positions.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates!
How to prepare for a job interview at Allerton Bishop Search
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC regulatory requirements, especially those related to NDA and MAA submissions. Be prepared to discuss specific examples from your past experience where you successfully navigated these processes.
✨Showcase Your Leadership Skills
As a Senior Regulatory CMC Project Manager, you'll need to demonstrate your ability to lead cross-functional teams. Think of instances where you've driven complex projects or coordinated with various stakeholders, and be ready to share these stories during the interview.
✨Understand the Bigger Picture
Familiarise yourself with the company's pipeline and the specific therapy they are developing. Showing that you understand how your role fits into their overall strategy will impress the interviewers and highlight your genuine interest in the position.
✨Prepare for Regulatory Scenarios
Anticipate questions about potential regulatory challenges and how you would address them. Consider recent changes in FDA or EMA guidelines and be ready to discuss how these might impact the company’s submission strategies.
