Senior Global Regulatory Scientist — Interventional Oncology

Janssen-Cilag Limited; Leiden; On-site; EUR 66,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Comprehensive benefits

Travel opportunities

Job summary

Johnson & Johnson Innovative Medicine is seeking a Sr. Regulatory Scientist to support global regulatory submissions for interventional oncology products.

The role involves coordinating IND/CTA/NDA/MAA filings, advising on documentation strategies, and aligning with local operating companies to meet submission timelines. The successful candidate will bring broad regulatory experience across product types, strong collaboration skills, and a track record in regulatory strategy and life cycle

Qualifications

• Bachelor’s Degree in a scientific subject with 6 years of industry experience or Master’s with 4 years of experience, or PharmD/PhD with 2 years of experience.
• Experience across product types (pharma, devices, combo products) preferred.
• Solid understanding of FDA and ICH regulatory requirements and guidelines for clinical research and life cycle submissions.

Responsibilities

• Prepare and support regulatory submissions (IND, CTA, NDA/MAA, eCTD).
• Advise on documents and strategies for NDA/MAA and other global filings.
• Support marketing authorization submissions and ensure timely document readiness.
• Liaise with LOCs and coordinate responses to health authorities.
• Participate in global regulatory team meetings and strategy development.

Skills

Regulatory submissions

Global regulation knowledge

Cross-functional collaboration

Regulatory strategy

Project management

Education

Bachelor's degree in science

Master's degree in a related field

PharmD/PhD with 2 years experience

Job description

Johnson & Johnson Innovative Medicine is seeking a Sr. Regulatory Scientist to support global regulatory submissions for interventional oncology products.

The role involves coordinating IND/CTA/NDA/MAA filings, advising on documentation strategies, and aligning with local operating companies to meet submission timelines. The successful candidate will bring broad regulatory experience across product types, strong collaboration skills, and a track record in regulatory strategy and life cycle