Location: Remote – Europe (Germany, Spain, Poland, or other EU countries)
Contract: 12 months
Start Date: January
Hours: Full-time, 5 days per week
Languages: Fluent Spanish and English required
Experience Level: Senior – Regulatory Affairs / CMC
Pay rate: Experience dependent!!! Please enquire.
Contact: Alex Roberts – aroberts@axion-search.com – 07572302937 (whatsapp me!)
Axion Search is seeking a Senior Manager Regulatory Affairs / CMC Strategist to lead operational teams and drive the regulatory lifecycle management of pharmaceutical products for our client. This role directly contributes to the company’s revenue growth and margin by ensuring regulatory compliance and product supply continuity, with a focus on Spanish regulations and EU compliance.
The successful candidate will combine regulatory expertise, technical CMC knowledge, and leadership to manage submissions, post-approval changes, and global regulatory strategies.
Key Responsibilities
Regulatory Strategy & CMC Leadership
- Lead the development and execution of global product and project regulatory strategies.
- Assess CMC changes, identify global regulatory requirements, evaluate supporting documentation, and mitigate potential risks.
- Ensure compliant execution of change management activities in collaboration with clients and external partners.
CMC Documentation & Lifecycle Management
- Manage execution and authoring of CMC documentation (Modules 1, 2, and 3) for lifecycle management, including post-approval supplements, annual reports, registration renewals, and responses to health authority questions.
- Compile, review, and validate Chemistry, Manufacturing, and Controls documentation.
- Perform CMC compliance activities including gap analysis, CMC comparisons, and validation for quality reports.
- Author assessment reports and Part 2 / expert reports for dossiers.
Collaboration & Cross-Functional Coordination
- Partner with manufacturing, quality, and cross-functional teams to ensure accurate, timely data for submissions.
- Work closely with internal and external stakeholders to support regulatory objectives while maintaining strict compliance with applicable guidelines.
Regulatory Knowledge & Compliance
- Maintain up-to-date knowledge of Spanish and EU regulatory guidelines, applications, and best practices.
- Apply regulatory expertise to benefit the company, ensuring timely approvals and continuity of product supply.
Qualifications & Skills
Required
- Bachelor’s or advanced degree in Pharmacy, Life Sciences, Chemistry, or related scientific field.
- 5+ years of Regulatory Affairs experience, with strong CMC focus.
- Fluency in Spanish and English (written and spoken).
- Deep understanding of Spanish regulations (AEMPS) and EU requirements.
- Experience authoring Modules 1–3 for regulatory submissions and lifecycle management.
- Proven ability to lead regulatory teams and projects.
- Strong project management, analytical, and problem-solving skills.
- Excellent attention to detail and technical writing skills.
Preferred
- Experience with global submissions and regulatory strategy development.
- Familiarity with change management, validation, and quality systems.
- Experience working with cross-functional and international teams
