Role Overview
This is a newly opened position within a small and growing team focused on Chemistry, Manufacturing, and Controls (CMC) lifecycle management for the EMEA region. The team currently includes two members based in Europe and collaborates closely with colleagues in Japan and the US. The successful candidate will play a key role in managing regulatory activities across multiple products, primarily small molecules, with the opportunity to expand into development projects over time.
The role offers a hybrid working model, with initial onboarding requiring 2–3 days per week on-site. Once settled, the role will shift to mostly remote work, with occasional in-person meetings as needed. Flexibility to work across time zones is essential.
Key Responsibilities
* Lead and support CMC lifecycle management activities for marketed and development-stage products in the EMEA region.
* Prepare and manage regulatory submissions including IMPDs and CTAs.
* Collaborate with cross-functional teams across global regions to ensure alignment and compliance.
* Handle multiple projects simultaneously, maintaining high standards of quality and accuracy.
* Contribute to strategic planning and execution of regulatory activities.
* Maintain up-to-date knowledge of regional regulatory requirements and industry best practices.
Candidate Profile
* Experience: Minimum 3 years of hands-on CMC lifecycle management experience within the EMEA region.
* Product Focus: Strong background in small molecules is essential; experience with biologics is a plus but not required.
* Education: Minimum BSc in Chemistry, Biological Sciences, Pharmacy, or a related field.
* Background: Candidates with laboratory experience are highly encouraged to apply.
* Skills:
* Proven ability to manage multiple projects and deadlines.
* Strong communication and collaboration skills.
* Detail-oriented with a proactive and motivated approach.
* Comfortable working in a dynamic, fast-paced environment.
* Motivation: Looking for candidates who are genuinely interested in long-term engagement and contributing meaningfully to the team’s growth and success.