Regulatory Affairs Manager

Quotient Sciences: Molecule to Cure. Fast. Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.

Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.

Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

As the Regulatory Affairs Manager, you will act as Regulatory Lead, and will be responsible for obtaining regulatory (MHRA), ethics, and ARSAC approval for Phase 1 clinical trials at Quotient Sciences, and for any Phase 1/2 trials managed by the organization. You will ensure compliance with all relevant regulations and guidance, including GxP standards, and maintain a strong understanding of the regulatory framework underpinning clinical trials.

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• Act as Regulatory Lead for cross-functional teams.
  
• Coordinate, plan, and deliver regulatory submissions, including Combined Review submissions to MHRA and ethics committees, ARSAC applications, RFIs, and amendments.
  
• Prepare, review, and quality-check key trial documents.
  
• Serve as primary contact for sponsors, MHRA, RECs, and ARSAC, negotiating practical solutions to regulatory comments.
  
• Lead regulatory discussions in sponsor and internal meetings.
  
• Advise colleagues on regulatory matters and manage urgent safety measures.
  
• Contribute to continuous quality improvement initiatives and CAPA processes.
  
• Provide training and mentorship to regulatory team members.
  
• Participate in audits and inspections by regulatory authorities.
  
• Support business development activities related to regulatory services.
  
• Maintain regulatory documentation and databases.
  
• Author and review regulatory SOPs and manage ARSAC licences.
  

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• Several years of relevant regulatory experience in a pharmaceutical company or CRO.
  
• Thorough knowledge of laws and guidance applicable to Phase 1 clinical trials.
  
• Proven ability to lead regulatory applications and submissions.
  
• Strong project leadership and teamwork skills.
  
• Excellent written and verbal communication skills.
  
• Ability to develop innovative solutions to regulatory challenges.
  
• High attention to detail and ability to manage multiple projects under tight deadlines.
  

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• High concentration and strict deadlines.
  
• Ability to juggle multiple tasks and work outside normal hours when required.
  
• Strong customer focus and responsiveness to sponsor requirements.
  

Join Quotient Sciences and play a pivotal role in advancing clinical research through regulatory excellence.

When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.