Immunology Regulatory Program Lead

Biopharma Asia; Cork; Híbrido; EUR 64.000 - 103.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Descripción de la vacante

Johnson & Johnson Innovative Medicine in Ireland (Ringaskiddy, Cork) seeks a Senior Analyst, Regulatory Program Manager – Immunology. You will lead cross-functional regulatory programs, translate strategy into executable plans, and ensure timely submissions and health authority interactions.

This role requires a bachelor’s degree (advanced degree preferred), at least 4 years in pharma/MedTech, strong project management, and travel up to 10%. Experience with Veeva and MS Project is a plus.

Formación

• Minimum of a Bachelor’s degree is required.
• Advanced degree is preferred.
• Minimum of 4 years of industry/business experience with at least 2 years in a Pharmaceutical, MedTech or comparable R&D area.
• Project management experience leading cross-functional teams.
• High proficiency and demonstrated application of project management standards, planning and visualization tools.
• Must have excellent verbal and written communication skills.
• Must have strong innovative and strategic thinking skills.
• Ability to travel up to 10% domestically and internationally.

Responsabilidades

• Serve as key facilitator within the RPM department to assigned service area to help ensure proper visibility to book of work, monitoring quality and process to support the success of the RPM department.
• Function as a change management and implementation leader for new process and system rollout across RPM team.
• Lead operations with Global Regulatory Team (GRT), including health authority meeting planning, submissions, and launch strategy.
• Translate regulatory requirements and strategy into an executable plan with clear detail for teams.
• Provide strong operational leadership to Regulatory and program teams.
• Support the Global Regulatory Team in meetings and cross-functional communications.
• Lead the operational execution of select regulatory submissions and strategies.

Conocimientos

Project management

Cross-functional leadership

Stakeholder communication

Strategic thinking

Problem solving

Travel readiness

Educación

Bachelor’s degree

Advanced degree

Herramientas

Veeva platform

Microsoft Project

Descripción del empleo

Johnson & Johnson Innovative Medicine in Ireland (Ringaskiddy, Cork) seeks a Senior Analyst, Regulatory Program Manager – Immunology. You will lead cross-functional regulatory programs, translate strategy into executable plans, and ensure timely submissions and health authority interactions.

This role requires a bachelor’s degree (advanced degree preferred), at least 4 years in pharma/MedTech, strong project management, and travel up to 10%. Experience with Veeva and MS Project is a plus.