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̽»¨ºÏ¼¯ is working with a innovative pharmaceutical company who are seeking Regulatory Strategist to support regulatory CMC submissions, focusing on lifecycle management for various markets. This role involves ensuring compliance with local regulations, managing HA queries, and collaborating cross-functionally to meet commercial objectives. The position is based in Surrey with potential flexibility for remote work after training.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Support regulatory CMC submissions, focusing on lifecycle management and multi-market projects.
• Ensure compliance with corporate policies and local regulations.
• Manage regulatory activities and resolve issues promptly.
• Translate local regulatory requirements into product strategies.
• Collaborate with key partners to ensure submission-ready dossiers.
• Provide input on technical issues and regulatory expectations.
• Drive Portfolio Management activities.
• Communicate regulatory positions effectively.
• Author local submission components as needed.
• Review submissions for consistency and completeness.
• Coordinate with global strategists on regulatory queries.
• Maintain accuracy of regulatory requirements in the system.
• Foster positive relationships internally and externally.
• Hold accountability for results and commitments.

Key Skills and Requirements:

• Bachelor's degree in Chemistry, Pharmacy, or a related life science.
• Advanced degrees (MSc, MBA, PhD) are advantageous.
• Experience in Regulatory Affairs, Conformance, or Compliance in the pharmaceutical industry.
• Strong background in IDM regulatory procedures.
• Knowledge of the Korean regulatory environment is desirable.
• Proactive and forward-looking mindset.
• Knowledge of IDM regulatory environments (EU, EME, ANZ, Canada, Korea, UK).
• Competence in understanding CMC submissions and regulatory risks.
• Knowledge of drug development practices and guidelines.
• Strategic and analytical thinking.
• Strong communication and collaboration skills.
• Quality and compliance orientation.
• Adaptability to change.
• Fluent in English (written and spoken).

If you are having difficulty in applying or if you have any questions, please contact Caitlin Siljeur at c.siljeur@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.