At a Glance
- Tasks: Lead global CMC regulatory strategies and ensure compliance for innovative pharmaceutical products.
- Company: Join a leading global pharmaceutical company dedicated to improving patient outcomes.
- Benefits: Enjoy a hybrid working model, annual bonus, and ongoing professional development.
- Other info: Opportunity for visibility across global teams and involvement in major regulatory submissions.
- Why this job: Make a real impact in a collaborative environment while advancing your career in regulatory affairs.
- Qualifications: Degree in a relevant life science and significant CMC regulatory experience required.
The predicted salary is between 63000 - 77000 £ per year.
Location
Hertfordshire (Hybrid, 2 days onsite)
Position
Permanent, Full-Time
Cpl Life Sciences is partnering with a leading global pharmaceutical company with a broad portfolio spanning innovative medicines across multiple therapeutic areas.
The organisation is committed to advancing treatments that improve patient outcomes worldwide and offers a highly collaborative, science-driven environment where Regulatory Affairs plays a strategic role throughout the product lifecycle.
This is an excellent opportunity for an experienced
CMC Regulatory Affairs professional to lead global CMC regulatory activities across both development-stage and commercial products, working closely with cross-functional teams including Pharmaceutical Development, Manufacturing, Quality, Analytical Development and Global Regulatory Affairs.
The Role
Senior Manager, CMC Regulatory Affairs
, you will be responsible for developing and executing global CMC regulatory strategies that support product development, registration, lifecycle management and post-approval regulatory compliance.
You will act as the CMC Regulatory lead for multiple projects, providing strategic guidance on complex technical, quality and regulatory issues while ensuring alignment with global health authority expectations.
This position offers significant exposure to late-stage development programmes, global registrations, product lifecycle management activities and agency interactions across key international markets.
Key Responsibilities
- Global CMC Regulatory Strategy
- Develop and implement global CMC regulatory strategies for development and marketed products.
- Provide strategic regulatory input to cross-functional project teams from early development through registration and post-approval maintenance.
- Assess regulatory risks and develop mitigation plans to support successful submissions and approvals.
- Act as the primary CMC Regulatory representative within cross-functional development teams.
- Regulatory Submissions & Authoring
- Lead the preparation, review and delivery of high-quality CMC regulatory documentation for:
- INDs, IMPDs and CTAs
- NDAs, BLAs and MAAs
- Variations, supplements and renewals
• Author and review CTD Module 3 documentation covering
- Drug Substance
- Drug Product
- Manufacturing processes
- Process validation
- Analytical methods and validation
- Control strategies
- Stability programmes
- Comparability assessments
- Coordinate submission activities across global markets and regional regulatory teams.
- Technical CMC Leadership
- Provide regulatory guidance on pharmaceutical development, manufacturing, analytical development and quality-related activities.
- Support process changes, manufacturing transfers, scale-up activities and technology transfer programmes.
- Review and assess proposed changes from Quality, Manufacturing and Technical Operations teams and determine the associated regulatory impact.
- Partner with SMEs to ensure technical data packages meet current regulatory expectations and ICH requirements.
- Health Authority Interactions
- Support regulatory agency interactions including scientific advice meetings, briefing documents and responses to agency questions.
- Lead preparation of responses to CMC-related deficiencies, information requests and regulatory commitments.
- Maintain awareness of emerging global CMC regulatory expectations and industry best practices.
- Drive improvements to internal regulatory processes, compliance standards and operational efficiencies.
- Contribute to regulatory intelligence activities and interpretation of evolving CMC guidance.
- Candidate Profile
- Degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, Pharmacy or related Life Science discipline.
- Significant experience within
CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Proven experience supporting global product development and registration activities.
- Strong understanding of ICH, FDA, EMA and international CMC regulatory requirements.
- Experience authoring and reviewing CTD Module 3 documentation.
- Ability to interpret complex technical, manufacturing and quality data and translate it into effective regulatory strategies.
- Technical Expertise
Candidates should possess a strong understanding of
- Drug substance and drug product development
- Pharmaceutical manufacturing processes
- Analytical development and validation
- Process validation and continued process verification
- Stability strategies and shelf-life justification
- Change control and lifecycle management
- Quality risk management principles
- GMP and quality systems
- CMC requirements across global regulatory markets
- Preferred Experience
- Advanced degree (MSc, Ph D or Pharm D) in a scientific discipline.
- Experience supporting both small molecule and biologic products.
- Experience leading CMC aspects of major regulatory submissions and approvals.
- Direct experience interacting with regulatory agencies on CMC matters.
- What's on Offer
- Annual bonus
- Hybrid working model (2 days onsite)
- Ongoing professional development and career progression opportunities
- Collaborative international environment with significant visibility across global regulatory and development teams
Senior Manager, CMC Regulatory Affairs in England employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration in the biotechnology sector. With a strong focus on employee growth and development, team members benefit from hybrid working arrangements in West London, allowing for a balanced work-life integration while contributing to groundbreaking projects in regulatory affairs. The company values continuous improvement and provides opportunities for meaningful contributions to the advancement of healthcare solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, CMC Regulatory Affairs in England
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We think you need these skills to ace Senior Manager, CMC Regulatory Affairs in England
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 Cpl Life Sciences!
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 Cpl Life Sciences 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 Cpl Life Sciences!
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 Cpl Life Sciences, 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 Cpl Life Sciences
✨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 Cpl Life Sciences 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 Cpl Life Sciences’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.
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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.
