Hobson Prior are working with a clinical-stage biopharmaceutical organisation, who currently have an exciting opportunity for an experienced CMC Regulatory Affairs Director to take a leadership role for developing global CMC regulatory strategies and content plans for products across the organisations cell and gene therapy portfolio.

Job Responsibilities:

• Develop and execute global CMC regulatory strategy for assigned products; ensuring CMC strategy is in alignment with the global regulatory strategy, organisation's portfolio strategy, commercial strategy, and the Target Product Profile.
• Act as the CMC Regulatory Lead on CMC Teams, representing the CMC Regulatory viewpoint and expertise on the CMC Team.
• Identify potential CMC regulatory risks to the strategic / operational plans and propose options to mitigate risks.
• Plan, prepare, review CMC related submission documentation and to provide input to and be accountable for the preparation of CMC dossiers for submission to Health Authorities (BLA / MAA / IND / CTA etc.).
• To plan, prepare, review 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 lead meetings with Health Authorities in connection with CMC regulatory questions and engage in appropriate interactions to increase the predictability of regulatory outcome.
• Deliver input to plans associated with manufacturing sites, commercial packaging selection and supply chain where decisions may have an impact on the filing strategy.
• Ensure compliance with Health Authority CMC related Regulations and ensure awareness of cell and gene therapy guidelines;
• Communicate with cross-functional CMC and manufacturing team members and external providers to ensure timely and effective regulatory submissions in support of product progression.
• Responsible for development and training of CMC staff in regulatory matters and to communicate the impact of new regulatory requirements across the Company.

Key Skills:

• Ability to provide technical input, proven ability to plan, coordinate and author regulatory documents simultaneously on multiple projects.
• Excellent communication skills with excellent presentation skills and the ability to work collaboratively.
• Proven strong organisational and strategic skills.
• Proven negotiating and influencing skills.

Requirements:

• A minimum of 10 years' 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 biologic drug development and US INDs/BLAs, EU CTAs/MAAs.
• Submissions with cell and or gene therapies
• Strong experience with interfacing with the health authorities globally and an excellent track record of building relationships with regulators and influencing regulatory outcomes.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.