CMC Regulatory Lead for Drug–Device Combinations

Johnson & Johnson Co.; Geel; Híbrido; EUR 96.000 - 165.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being programs

Descripción de la vacante

Johnson & Johnson is recruiting for a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. The role is hybrid and can be located in Beerse, Belgium or Warsaw, Poland.

You will lead regulatory strategies for complex combination products and provide expert guidance across global regulatory requirements and Health Authority interactions. The position requires a minimum of 10 years in Regulatory Affairs, with strong leadership, negotiation, and strategic problem-solving skills,

Formación

• Bachelor’s degree or equivalent in scientific/engineering fields required.
• Advanced degree preferred (Master’s, PharmD, Ph.D.).
• Minimum 10 years of Regulatory Affairs/Quality experience.

Responsabilidades

• Lead complex regulatory strategies for drug-device and combination products.
• Provide expert interpretation of global regulatory requirements and Health Authority interactions.
• Mentor and coach cross-functional teams and drive lifecycle management.
• Represent Johnson & Johnson in external regulatory activities and industry forums.

Conocimientos

Regulatory strategy

Senior leadership

Stakeholder management

Regulatory compliance

Strategic thinking

Technical writing

SME collaboration

Public policies

Educación

Bachelor’s degree

Master’s/PhD preferred

Regulatory Affairs Certification (RAC)

Descripción del empleo

Johnson & Johnson is recruiting for a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. The role is hybrid and can be located in Beerse, Belgium or Warsaw, Poland.

You will lead regulatory strategies for complex combination products and provide expert guidance across global regulatory requirements and Health Authority interactions. The position requires a minimum of 10 years in Regulatory Affairs, with strong leadership, negotiation, and strategic problem-solving skills,