Director of Regulatory CMC - Cell Therapy

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.

We are looking for an experienced Regulatory Affairs professional to lead the CMC strategy for the future pipeline of the business. The role will require expert experience working with regulators and attending regulatory meetings to ensure a robust strategy, whilst imbedding themselves with the Product Development team to understand the manufacturing process and the products to minimise regulatory risk. This is a stand-alone role and requires the individual to work “hands on” but also strategically on multiple projects individually across the business

MAIN RESPONSIBILITIES

• To lead the development and execution of global CMC regulatory strategy across developing portfolio of products; ensuring CMC strategy is in alignment with the global regulatory strategy, product delivery strategy and the Target Product Profile (TPP).
• To build the CMC regulatory team as business need develops.
• To be embedded within the Product Delivery team to ensure that high quality regulatory strategy and guidance is provided to support product development strategy.
• To ensure potential CMC regulatory risks and opportunities to the strategic/operational plans are identified and ensure risk mitigation plans are developed.
• To plan, prepare and review CMC related submission documentation and to provide input to and be accountable for the preparation of CMC dossiers for submission to Health Authorities.
• To provide leadership in the preparation and review of CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings.
• To provide CMC regulatory support to pre-approval and GMP inspections.
• To provide input to plans associated with manufacturing site(s) and supply chain strategy where decisions may have an impact on filing strategy.
• Ensure compliance with Health Authority CMC-related Regulations and ensure awareness of cell and gene therapy guidelines.
• Liaise with cross-functional Product Delivery and Clinical Team Members and external providers to ensure timely and effective regulatory submissions in support of product progression.
• To be responsible for the development and training of relevant staff in regulatory matters and to communicate the impact of new regulatory requirements across the Company.
• To raise the profile with external stakeholders and shape the regulatory environment to support the development of the portfolio.
• To ensure CMC regulatory is a trusted partner at all levels of our business.
• Development of CMC regulatory procedures to support the development of our QMS.
• Support the Head of Regulatory to build operational and technological capabilities within the Regulatory function to ensure world class delivery of regulatory strategy

EXPERIENCE WE ARE LOOKING FOR

• A breadth of experience in Regulatory Affairs with a core expertise in CMC
• Excellent working knowledge of FDA and EU CMC Regulations and guidelines related to cell and gene therapies.
• Significant experience in CMC biological drug development, US INDs/BLAs, EU CTAs/MAAs; particularly in the field of cell and/or gene therapies.
• Strong experience with interfacing with global Health Authorities and an excellent track record of building relationships with regulators and influencing regulatory outcomes.
• Ability to provide technical input, proven ability to plan, coordinate and author regulatory documents.
• Ideally experience working in a smaller biotech startup.

LEADERSHIP SKILLS REQUIRED

• Ability to engage and influence across core internal and external stakeholders to ensure focus on value generation, whilst role modelling the core values
• Seasoned in both seeking and providing development-based feedback to others, with a continuous improvement mindset
• Agile approach to change, with the ability to adapt and drive initiatives that capitalise on opportunities

PERSONAL QUALITIES

• Excellent team working and networking skills with experience of interacting effectively across
• interfaces of discipline, culture, and expertise
• Desire to work with integrity and act as an ambassador for the wider business.

BENEFITS

• Holidays: 25 days per year
• Life Assurance: 4 x base salary
• Group Personal Pension: Auto enrolled at 6% employer contribution, 3% employee contribution
• Private Medical Insurance for your whole family
• Annual Bonus
• Equity Scheme

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.