Global Regulatory CMC Leader: Strategy & Authorities

Jobtailor; Søborg; On-site; DKK 1,100,000 - 1,700,000; Full time

Job summary

Jobtailor seeks a Lead Regulatory Affairs CMC professional to steer global regulatory strategies and execution for early development across indications.

You will lead interactions with authorities such as FDA and EMA, prepare briefing documents, and ensure alignment across Regulatory Affairs, CMC Development, QA and Clinical Supply. This role requires strong cross‑functional influence, excellent communication, and a proactive approach to navigate regulatory challenges in international markets.

Qualifications

• Master's degree in Regulatory Affairs and relevant regulatory experience.
• Knowledge of global regulatory requirements across major markets.
• Strong understanding of CMC development, manufacturing and value chain.
• Experience leading complex regulatory CMC projects.
• Ability to influence cross-functional stakeholders in international environments.
• Proven track record in regulatory risk management and clear advisory output.
• Excellent communication, negotiation, and stakeholder management skills.
• Fluency in written and spoken English.

Responsibilities

• Lead global regulatory CMC strategies and execution for early development.
• Manage interactions with health authorities, incl. briefing documents and meeting strategies.
• Ensure alignment across Regulatory Affairs, CMC Development, QA, Clinical Supply and affiliates.
• Represent Regulatory Affairs in cross-functional matrix teams.
• Drive strategic alignment and information sharing across functions.
• Contribute to regulatory intelligence, innovation and external engagement.
• Solve complex regulatory challenges to support business objectives globally.
• Collaborate with Product Supply, Global Research, Medical Affairs, and other functions.

Skills

Regulatory leadership

Stakeholder management

Cross-functional collaboration

Regulatory strategy

Regulatory risk management

Communication skills

English proficiency

Education

Master's degree in Regulatory Affairs

Job description

Jobtailor seeks a Lead Regulatory Affairs CMC professional to steer global regulatory strategies and execution for early development across indications.

You will lead interactions with authorities such as FDA and EMA, prepare briefing documents, and ensure alignment across Regulatory Affairs, CMC Development, QA and Clinical Supply. This role requires strong cross‑functional influence, excellent communication, and a proactive approach to navigate regulatory challenges in international markets.