Distinguished Scientist, CMC Regulatory Affairs - Combination Products

About the role

Johnson & Johnson is looking for a Distinguished Scientist, CMC Regulatory Affairs - Combination Products, based in Allschwil, Switzerland. The role provides scientific and CMC regulatory leadership for novel, ambiguous and complex combination products and other drug-device programs where regulatory expectations are evolving or inconsistently applied across regions. It is a senior scientific position in the Discovery & Pre-Clinical/Clinical Development area, reporting to the CMC RA leadership team.

Key responsibilities

• Drive innovative CMC regulatory strategies and advance regulatory knowledge for complex combination products and drug-device programs.
• Represent J&J in external regulatory, industry, trade association, benchmarking and policy-shaping forums.
• Partner with regulatory intelligence and policy stakeholders to identify gaps and set coordinated external influencing priorities.
• Serve as CMC RA Combination Product lead for selected programs and give strategic advice to others.
• Interpret and guide regulatory strategy where precedents are limited, and mentor less experienced colleagues.
• Bridge external and program learning back to the department and business partners.

Required profile

• Bachelor's degree in biology, pharmacy, chemistry, engineering, regulatory science, medical devices or another relevant scientific discipline.
• Minimum 12 years of relevant experience in pharma, biotech, medical devices or regulated healthcare.
• Significant experience in CMC Regulatory Affairs, regulatory affairs or a related regulated function.
• Experience as CMC RA lead or key contributor, including regulatory risk assessments, mitigation plans and Health Authority engagement strategies.
• Experience with device submissions (IDEs, 510(k)s, PMAs, technical files, EU CIIA) and Health Authority interactions.
• Ability to influence senior stakeholders in a global matrix environment; 5% domestic or international travel required.
• Authorization to work in the country of employment; immigration sponsorship and relocation support are not available.

Required skills

• Drug-device combination product regulatory strategy and global CMC regulatory submissions.
• Knowledge of medical device quality systems, device risk management, human factors/usability engineering and investigational devices.
• Preferred: deep knowledge of global combination product and device requirements, mentoring ability, and framework development.