Regulatory Principal Specialist – RA CMC Development

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

• Lead global regulatory CMC strategies and execution for early development across indications and modalities
• Manage interactions with global health authorities, including preparation of briefing documents, regulatory meeting strategies, and responses to agency questions
• Act as Regulatory Affairs CMC Lead, ensuring alignment across Regulatory Affairs, CMC Development, Quality Assurance, Clinical Supply, affiliates, and other key stakeholders
• Represent Regulatory Affairs within cross-functional matrix teams
• Drive strategic alignment and information sharing across functions
• Contribute to innovation, process optimisation, regulatory intelligence, and external industry engagement
• Solve complex regulatory challenges and support key business objectives across global markets
• Collaborate with experts across Product Supply, CMC Development, Global Research, Clinical Operations, Medical Affairs, Safety, Device Development, Marketing, and affiliates worldwide
• Engage with regulatory authorities such as the FDA, EMA, and other agencies

Requirements

• A Master's degree with significant Regulatory Affairs experience
• Deep knowledge of global regulatory requirements, including drug development and health authority interactions across major markets
• Strong understanding of CMC development, manufacturing, and the pharmaceutical value chain
• Demonstrated experience leading complex regulatory CMC projects
• Experience influencing cross-functional stakeholders and driving strategic decision-making in an international environment
• Proven track record managing regulatory risks and translating challenges into clear, actionable advice
• Excellent communication, negotiation, and stakeholder management skills
• Fluency in written and spoken English
• Proactive, accountable, and able to navigate complexity
• Ability to build strong relationships across functions and cultures
• Ability to make difficult decisions and balance scientific insight with business priorities

Core Competencies

Demonstrates expertise in leading global regulatory CMC strategies and managing interactions with health authorities, ensuring compliance with regulatory requirements while driving strategic alignment across cross-functional teams.

Highest-signal resume keywords

• Regulatory Affairs CMC Leadership
• Global Regulatory Requirements Knowledge
• CMC Development and Manufacturing Expertise
• Stakeholder Management and Influence
• Complex Regulatory Project Management

Hard Skills

• Regulatory CMC Strategy
• Drug Development Knowledge
• Regulatory Risk Management
• Regulatory Meeting Preparation
• Regulatory Intelligence
• Process Optimisation
• Pharmaceutical Value Chain Understanding
• Health Authority Interaction
• Regulatory Briefing Document Preparation
• Cross-Functional Collaboration

Soft Skills

• Excellent Communication
• Negotiation Skills
• Proactive Problem Solving
• Relationship Building
• Decision-Making

Certifications & Qualifications

• Master's Degree in Regulatory Affairs

Industry Keywords

• FDA
• EMA
• Global Health Authorities
• Clinical Operations
• Medical Affairs
• Product Supply
• Device Development
• Clinical Supply
• Quality Assurance
• Cross-Functional Matrix Teams