Impel Talent is leading the search for a pivotal regulatory affairs role on behalf of our confidential client—an international biopharmaceutical company focused on developing and delivering high-quality biosimilar medicines. With a strong global footprint across North America, Europe, and Asia, the company is committed to increasing patient access to affordable biologics through scientific excellence, regulatory expertise, and strategic partnerships.
About the Role:
As Regulatory Manager within the Global Regulatory Affairs (GRA) team, you’ll be at the intersection of science and strategy—supporting the development, approval, and lifecycle management of biosimilar products in key global markets. You will work alongside Global Regulatory Leads to shape worldwide regulatory strategies and prepare high-quality submission documentation (MAAs, BLAs, briefing books). This role is key in ensuring that development programs remain on track and aligned with regulatory expectations, enabling successful product approvals and global market entry.
Key Responsibilities:
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Support or act on behalf of Global Regulatory Leads (GRLs) in executing regulatory strategies across development, licensure, and post-marketing phases.
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Represent the GRA Strategy function in cross-functional project teams, delivering unified regulatory perspectives and ensuring alignment across departments.
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Prepare and compile high-quality global regulatory submissions, including MAAs, BLAs, and Health Authority correspondence.
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Proactively identify regulatory risks and contribute to mitigation planning.
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Apply in-depth knowledge of ICH guidelines and global regulatory frameworks to product strategy.
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Collaborate with internal stakeholders and global partners to ensure submission consistency and commercial alignment.
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Support interactions with regulatory authorities, including meeting preparation and response management.
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Stay current with evolving regulatory landscapes and share insights with the wider team.
Minimum Qualifications:
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BSc (or equivalent) in biological or healthcare sciences.
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At least 5 years of regulatory experience within the pharmaceutical/biotech industry.
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Strong track record in biologics development and regulatory affairs, specifically in the US and EU.
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Proven experience with regulatory authoring and complex submission preparation.
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Excellent communication and cross-functional collaboration skills.
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Strong organisational skills with an ability to manage multiple projects.
Preferred Experience:
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Expertise in authoring global dossiers for biologics/biosimilars (EMA/FDA).
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Hands-on experience in managing MAA and/or BLA approvals.
