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US Regulatory Strategy Lead — FDA Pathways & Strategy

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Sobi - Swedish Orphan Biovitrum AB (publ)
Full Time position
Listed on 2026-07-04
Job specializations:
  • Business
    Corporate Strategy
Salary/Wage Range or Industry Benchmark: 185000 - 210000 USD Yearly USD 185000.00 210000.00 YEAR
Job Description & How to Apply Below

Sobi - Swedish Orphan Biovitrum AB (publ) is seeking a US Regulatory Strategy Lead responsible for developing and implementing regulatory strategies for their products in the US market. This pivotal role involves leading interactions with the FDA, preparing teams for FDA meetings, and ensuring timely and quality submissions. The ideal candidate should have over 6 years of regulatory affairs experience and a strong understanding of product development processes.

The role offers a competitive salary range of $185,000 to $210,000, with additional bonus opportunities based on performance and qualifications.

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