Senior Principal Scientist, CMC Regulatory Affairs - Combination Products

About the role

Johnson & Johnson Innovative Medicine R&D is recruiting a Senior Principal Scientist, CMC Regulatory Affairs for combination products, based in Allschwil, Switzerland. This is a hybrid role and a senior scientific and regulatory subject matter expert who leads complex combination product regulatory strategies, programs, projects and processes across multiple technical and regulatory areas. It may support pre-approval and post-approval programs, synthetic or biologic products and any therapeutic area.

Key responsibilities

• Serve as CMC Regulatory Affairs lead for complex, novel, high-risk or business-critical combination product programs, and as a core member of combination product development teams and an ad hoc member of the CMC, Value Chain and Global Regulatory teams.
• Interpret global combination product and medical device regulatory requirements and Health Authority expectations, and advise project teams and management on complex, high-risk or precedent-setting regulatory issues.
• Lead global regulatory strategies for clinical, marketing and lifecycle submissions, including risk assessments, mitigation plans and contingency planning.
• Review device and combination product submission content for clinical trial applications, marketing applications, Notified Body technical dossiers and design control deliverables.
• Lead regulatory assessments of manufacturing, device, user interface, platform and product changes, and prepare briefing books, scientific advice meetings and responses to Health Authorities.
• Represent the company in external regulatory, industry and scientific forums, including associations, standards development and working groups.
• Provide technical leadership, mentoring and coaching, and lead cross-functional initiatives on regulatory process improvement, guidance implementation, standards development and training.

Required profile

• Minimum of 10 years of relevant experience in Regulatory Affairs, Quality and/or Product Development.
• Experience in the pharmaceutical, biotechnology, medical device, combination product or other regulated healthcare environment.
• Bachelor's degree in a scientific, engineering, pharmaceutical, regulatory science or related discipline; advanced degree preferred.