Regulatory Affairs Specialist

Cornerstone International; München; Hybrid; EUR 60,000 - 85,000; Full time

Job summary

Cornerstone International Clinical is seeking a Regulatory Affairs Specialist to support regulatory submissions and strategy across the portfolio, bridging clinical development and regulatory science.

You will prepare CTAs, IND amendments, and annual reports, liaise with European authorities, and provide guidance to project teams on study design and labeling, while tracking regulatory developments and readiness for audits.

Qualifications

• Minimum three years of regulatory affairs experience in a clinical development environment.
• Experience with EMA submissions and familiarity with EU Clinical Trials Regulation (CTR).
• Strong attention to detail and ability to manage multiple submissions simultaneously.

Responsibilities

• Prepare and review regulatory submissions including CTAs, IND amendments, annual reports and safety updates.
• Liaise with regulatory authorities in Europe and other regions as required.
• Provide regulatory guidance to project teams on study design, protocol amendments and labelling questions.
• Track regulatory intelligence and update internal teams on relevant guidance documents and regulatory developments.
• Support audit and inspection readiness activities.

Skills

Regulatory affairs

Regulatory submissions

Attention to detail

Education

Degree in life sciences or related field

Tools

EMA submissions

Job description

Cornerstone International Clinical is building its regulatory affairs capability and is seeking a Regulatory Affairs Specialist to support clinical study submissions and regulatory strategy across the portfolio. This role sits at the intersection of clinical development and regulatory science.

Responsibilities

• Prepare and review regulatory submissions including CTAs, IND amendments, annual reports and safety updates
• Liaise with regulatory authorities in Europe and other regions as required
• Provide regulatory guidance to project teams on study design, protocol amendments and labelling questions
• Track regulatory intelligence and update internal teams on relevant guidance documents and regulatory developments
• Support audit and inspection readiness activities

Requirements

• Degree in pharmacy, medicine, life sciences or a related field
• Minimum three years of regulatory affairs experience in a clinical development environment
• Experience with EMA submissions and familiarity with EU Clinical Trials Regulation (CTR)
• Strong attention to detail and ability to manage multiple submissions simultaneously