Senior CMC Regulatory Scientist, Combo Products

Johnson & Johnson Co.; Beerse; Hybrid; EUR 96,000 - 165,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine in Beerse, Belgium, or Warsaw, Poland, seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. Hybrid role requiring leadership of regulatory strategies across drug-device combinations and global submissions.

You will mentor cross-functional teams, guide Health Authority interactions, and shape regulatory programs across multiple modalities, ensuring compliant lifecycle management and alignment with global standards.

Qualifications

• Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline.
• 10+ years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
• Knowledge of global regulatory requirements for drug-device combination products and medical devices.

Responsibilities

• Lead CMC Regulatory Affairs (RA) Combination Product programs and collaborate with cross-functional teams.
• Develop global regulatory strategies for clinical, marketing, and lifecycle submissions.
• Review device and combination product submission content including clinical trial applications and regulatory dossiers.
• Advise on regulatory requirements, risk assessments, and health authority interactions.
• Mentor and coach regulatory and cross-functional colleagues; represent the company in external regulatory activities.

Skills

Regulatory affairs

Global regulatory strategies

Communication skills

Leadership

Travel willingness

Education

Bachelor’s degree or equivalent in science/engineering/pharma/regulatory

Advanced degree preferred (Master’s/Ph.D./PharmD)

Job description

Johnson & Johnson Innovative Medicine in Beerse, Belgium, or Warsaw, Poland, seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. Hybrid role requiring leadership of regulatory strategies across drug-device combinations and global submissions.

You will mentor cross-functional teams, guide Health Authority interactions, and shape regulatory programs across multiple modalities, ensuring compliant lifecycle management and alignment with global standards.