Regulatory Specialist

4 weeks ago

London Area, United Kingdom Northreach Full time

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.


Overview

We are seeking a highly skilled and detail-oriented Regulatory CMC Specialist with expertise in cell therapy and ATMP to join a dynamic regulatory affairs team. This is an exciting opportunity to contribute to cutting-edge treatments in a fast-evolving field. Based in London with a flexible hybrid working model, you will play a pivotal role in driving regulatory compliance for transformative therapies.

Key Responsibilities

  1. Regulatory Documentation and Submissions:
  • Prepare and review high-quality CMC documentation for regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs) specific to cell therapy and ATMP products.
  • Ensure compliance with global regulatory requirements for ATMPs, including gene therapies, tissue-engineered products, and somatic-cell therapies.
  • Manage submissions for variations, renewals, and responses to regulatory agency queries.
  1. Cross-Functional Collaboration:
  • Collaborate closely with manufacturing, quality assurance, R&D, and clinical teams to compile technical data for regulatory submissions.
  • Serve as the regulatory CMC point of contact for ATMP-specific projects, ensuring alignment with manufacturing and clinical development objectives.
  1. Regulatory Strategy:
  • Develop and implement CMC regulatory strategies tailored to cell therapy and ATMP products, considering the unique regulatory landscape for advanced therapies.
  • Monitor and interpret evolving global regulatory guidelines for ATMPs, advising stakeholders on implications for product development and lifecycle management.
  1. Risk Assessment and Compliance:
  • Assess and mitigate risks associated with CMC compliance for complex biological systems and advanced therapies.
  • Conduct gap analyses of existing ATMP CMC dossiers, ensuring readiness for inspections and compliance with global regulatory expectations.
  1. Documentation and Systems Management:
  • Maintain accurate CMC regulatory documentation and databases specific to ATMPs, ensuring audit readiness.
  • Support audits and inspections by regulatory authorities, particularly regarding manufacturing and quality processes for cell therapies.

Qualifications and Experience

  • Education:
  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, Cell Biology, or related sciences.
  • Experience:
  • Minimum of 3–5 years’ experience in a Regulatory CMC role, with direct experience in cell therapy, gene therapy, or ATMPs.
  • In-depth understanding of regulatory requirements for ATMPs, including compliance with FDA, EMA, and ICH guidelines.
  • Hands-on experience with global regulatory submissions and lifecycle management for advanced therapies.
  • Skills:
  • Strong expertise in the manufacturing, characterization, and quality requirements for cell therapy/ATMP products.
  • Exceptional analytical and organizational skills with attention to detail.
  • Excellent written and verbal communication skills.
  • Familiarity with regulatory information management systems (RIMS) and electronic submission tools is advantageous.

What We Offer

  • Competitive salary and benefits package.
  • Flexible hybrid working environment with 3 days in the London office.
  • The opportunity to work on transformative therapies at the forefront of medicine.
  • Professional development opportunities in a rapidly growing field.
  • Inclusive and collaborative work culture.


Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.

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