Senior Regulatory Affairs Lead — Hybrid, Dossier Expert

Get 360Pharma; Bilthoven; Hybrid; EUR 50,610 - 80,541; Full time

Benefits offered by this job

Salary scale 11 (between €4,535 - €7,217)

Opportunities for professional development

100% continued payment during partner leave

Excellent commuting allowance

Year-end bonus (13th month)

Solid pension scheme (ABP)

On-site sports facilities

25 vacation days

Job summary

Get 360Pharma in Bilthoven is seeking a Regulatory Affairs professional to manage the regulatory dossiers of biological medicines. This role involves preparing regulatory submissions, maintaining compliance, and collaborating closely with production departments.

The ideal candidate should possess a master's or bachelor's degree in a biomedical discipline with at least 3-5 years of relevant experience in a global regulatory environment.

The position offers a competitive salary and opportunities for personal and professional development.

Qualifications

• Master's or Bachelor's degree in a biomedical discipline with significant RA experience.
• Strong knowledge of international regulatory guidance for biological medicines.
• At least 3-5 years of relevant RA experience within an international environment.

Responsibilities

• Prepare and submit regulatory dossiers for product registrations.
• Maintain regulatory dossiers and initiate variations as needed.
• Collaborate with various departments on regulatory impacts.

Skills

International regulatory guidance

GMP compliance

Pharmacovigilance knowledge

Excellent command of English

Education

MSc or BSc in biomedical discipline

Tools

eCTD

Regulatory IT systems

Job description

Get 360Pharma in Bilthoven is seeking a Regulatory Affairs professional to manage the regulatory dossiers of biological medicines. This role involves preparing regulatory submissions, maintaining compliance, and collaborating closely with production departments.

The ideal candidate should possess a master's or bachelor's degree in a biomedical discipline with at least 3-5 years of relevant experience in a global regulatory environment.

The position offers a competitive salary and opportunities for personal and professional development.