Alvotech, a leading global biopharmaceutical company, is hiring a Manager for Global Regulatory Affairs Life-Cycle Management (LCM) – Chemistry, Manufacturing, and Controls (CMC). This role is critical in supporting the regulatory strategy for biosimilar products, ensuring compliance with global regulations, and managing high-quality documentation for submissions.
If you have a strong background in regulatory affairs, CMC, and life-cycle management, this is an excellent opportunity to join a dynamic team and contribute to life-changing therapies.
Key Responsibilities
- Develop and execute regulatory LCM CMC strategies for biosimilar products.
- Represent the CMC regulatory team in cross-functional projects.
- Ensure alignment with global regulatory requirements (FDA, EMA, ICH guidelines).
- Assess and approve change controls for regulatory compliance.
- Prepare, review, and manage high-quality CMC documentation for submissions.
- Participate in health authority interactions (e.g., FDA, EMA).
- Collaborate with external partners to support commercial success.
- Identify and mitigate regulatory risks related to product life-cycle changes.
- Support the development of regulatory excellence tools and processes.
- Maintain an efficient and transparent working environment within Global Regulatory Affairs (GRA).
Candidate Profile
Education & Experience:
- PhD in Life Sciences/Pharmacy with 1-3 years of experience.
- MS/MPharm with 4-6 years of experience.
- BPharm/BS with 6-8 years of experience.
- Strong background in regulatory affairs, CMC, and biosimilars.
- Prior experience in life-cycle management and variation filings (US, EU).
Skills & Competencies:
- In-depth knowledge of ICH, FDA, EMA guidelines, GMP, and quality requirements.
- Ability to work in matrix teams and diverse cultures.
- Strong project management skills to keep initiatives on track and within budget.
- Fluency in English (additional languages are a plus).
- Ability to thrive in a fast-paced, dynamic environment.
How to Apply
Interested candidates meeting the eligibility criteria can apply before the last date: April 13, 2025.
