Principal Scientist, CMC Regulatory Affairs – Combination Products (1 of 2) Full-time

Principal Scientist, CMC Regulatory Affairs – Combination Products

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Job Function: Discovery & Pre-Clinical/Clinical Development

Job Sub Function: Regulatory Science

Job Category: Scientific/Technology

Location: Allschwil, Basel-Country, Switzerland

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Principal Responsibilities:

• Provide regulatory expertise and interpretation of global combination product and global medical device regulatory requirements, including evolving global Health Authority CMC expectations for drug-device combination products, their user interface, and devices, integral or separate, involved in the preparation or administration of drugs.
• Develop and execute regulatory strategies for clinical, marketing, and lifecycle management submissions involving combination products, including regulatory risk assessments and mitigation plans.
• Review device and combination product-specific submission content for clinical trial applications, marketing applications, Notified Body technical dossiers, and development and review of applicable design control deliverables.
• Provide regulatory assessments for manufacturing, device, and product changes and determine regulatory impact globally.
• Develop regulatory strategies for Health Authority interactions, briefing books, and responses related to combination product regulatory questions.
• Participate in cross-functional initiatives related to regulatory process improvements, guidance implementation, and capability development.
• Monitor emerging global device and combination product regulations and communicate regulatory impacts to project teams and management.
• Perform other duties in support of Global Regulatory Affairs, CMC Regulatory Affairs, combination product development, registration, lifecycle management, regulatory compliance, and organizational capability-building objectives. These activities may include participation in selected due diligence, internal consultation, process improvement, training, and cross-functional regulatory initiatives.

Qualifications:

• A minimum of a Bachelor's degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is required. Advanced degree (Master's, PharmD, Ph.D) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred.
• A minimum of 8 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development, inclusive of post-graduate education, is required.
• Experience in the pharmaceutical, biotechnology, medical device, combination product or other regulated healthcare environment is required.
• Knowledge of scientific, technical, regulatory, or product development principles relevant to regulated healthcare products.
• Ability to develop and execute regulatory strategies for assigned programs, submissions, Health Authority interactions, or lifecycle activities.
• Ability to collaborate cross-functionally and influence decision-making across a global, matrix organization.
• Excellent written and verbal communication skills.
• Strong analytical problem-solving skills.
• Strong attention to detail and organizational skills
• 10% domestic or international travel

Preferred Skills:

Benchmarking, Coaching, Consulting, Corporate Governance, Critical Thinking, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Organizing, Public Policies, Regulatory Compliance, Regulatory Development, Scientific Research, Strategic Thinking, Subject Matter Experts (SME) Collaboration, Technical Writing