At Alvotech, our Global Regulatory Affairs (GRA) team is dedicated to bridging the gap between science and worldwide regulatory authorities to deliver affordable biosimilar medicines. We are looking to hire an experienced Regulatory Manager to support Global Regulatory Leads (GRLs) in all aspects of Global regulatory product development strategy. This is a unique opportunity to work directly on EU, US and Japan regulatory submissions and gain true global experience working in dynamic teams.
Key Responsibilities:
Support GRLs in overseeing regulatory strategic aspects for development and post-approval activities.
Compile and prepare high-quality regulatory documentation for global submissions (INDs, MAAs, BLAs, briefing books, responses to questions, etc.).
Assist in developing worldwide regulatory strategies for biosimilar products.
Represent GRA Strategy in cross-departmental teams, providing unified regulatory advice and project status updates.
Ensure a single, aligned GRA message at interdisciplinary meetings.
Identify regulatory risks and propose mitigation strategies.
Apply knowledge of ICH and Global Regulatory guidelines, GMP, and quality requirements.
Participate in health authority interactions and responses.
Interface with external partners and cross-functional teams to ensure global dossier alignment and support commercial success.
Perform activities to keep assigned projects on track.
Engage in continuous professional development to stay updated on new regulatory requirements and technical developments.
Job Requirements:
BSc (or equivalent) in biological or healthcare science + 5 years in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent.
Extensive experience in Regulatory Affairs with expertise in biologics for US and EU markets.
Strong regulatory authoring skills and willingness to support key regulatory documents.
Expertise in global dossier authoring for biologics/biosimilars (EMA/FDA).
Direct experience managing MAA/BLA approvals.
Fluency in English with strong communication skills.
Ability to work collaboratively across diverse teams.
Ability to work effectively in a fast-paced dynamic environment.
Excellent multitasking and attention to detail.
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What we offer:
An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
The chance to be a part of a global and fast-growing company.
An international work culture that encourages diversity, collaboration and inclusion.
Positive, flexible, and innovative work environment.
Support for personal growth and internal career development.
Internet at home for full-time employees.
Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.
Regulatory Manager