Regulatory Support Lead – MSAT
Location: Stockholm, Sweden
Job Type: Full-time
Application Deadline: June 22, 2025
Alvotech is seeking an experienced Regulatory Support Lead to join the Manufacturing Science and Technology (MSAT) department. This role is critical in bridging regulatory and manufacturing operations, ensuring all documentation, processes, and submissions meet global regulatory expectations including EMA, FDA, and RoW markets.
Scope & Responsibilities:
Act as the key liaison between Manufacturing and Regulatory functions to drive regulatory strategy and execution.
Lead authoring of dossier sections related to drug substance (DS) and drug product (DP) manufacturing processes and controls for regulatory filings.
Ensure all CMC submissions are in compliance with current GMP regulations.
Collaborate with PharmSci, process development, and other cross-functional teams to co-author and refine critical sections of regulatory dossiers.
Provide timely regulatory support during product approvals, responding to deficiency letters from health authorities, and updating dossier content accordingly.
Participate in lifecycle management of commercialized biosimilar products, assessing regulatory impact of manufacturing changes.
Ensure that dossiers align with approved manufacturing documentation and facilitate corrections where needed.
Represent MSAT during regulatory discussions and inspections, offering expert insight and support during health authority audits.
Job Requirements:
MBA in International Business and a Bachelor’s degree in Biotechnology or a related field.
At least 10 years of relevant experience in Biopharmaceutical Regulatory Affairs and Biosimilar Manufacturing.
Strong expertise in the manufacturing of monoclonal antibodies (both DS and DP).
Up-to-date knowledge of global regulatory and GMP guidelines.
Proven ability to lead regulatory documentation and cross-functional coordination.
Skilled in regulatory risk assessment, technical problem-solving, and process validation strategies.
High attention to detail and strong documentation discipline, particularly in SOPs, PDDs, and regulatory-impacting documentation.
What We Offer:
A meaningful role with the opportunity to positively impact global healthcare access.
A fast-growing, global organization with a supportive and international work culture.
Inclusive, diverse, and innovative workplace environment.
Encouragement and support for professional growth and career development.
Flexibility in work setup, including internet at home for full-time employees.
Why Join Alvotech:
At Alvotech, we are driven by the mission to improve lives through affordable biologics. Rooted in our Icelandic values of fairness, integrity, and equality, we foster a workplace where ideas thrive, and people are empowered. Our commitment to simplicity, ingenuity, and accessibility is reflected in our team’s passion for delivering biosimilar solutions worldwide.
Estimated Salary: €90,000 – €110,000
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Hebron | Nebraska City |Nevada :
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China | Quarry Bay |Hubei :
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Canada |Ontario :
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