Regulatory Affairs Specialist - RA Manufacturing Facilities & Projects

The position

is based in Søborg, Denmark, and offers exposure to global projects as well as close collaboration with colleagues across cultures and time zones. Your skills and qualifications You bring a strong scientific and technical foundation, built through your education and extensive experience within pharmaceutical operations, including manufacturing, CMC process development, quality assurance, and regulatory affairs. To succeed in this role, you are expected to have: A university degree in Pharmaceutical Engineering, Life Sciences, or a related field. At least 8 years of relevant experience within regulatory affairs, manufacturing, and quality in the pharmaceutical industry. Proven experience with regulatory submissions and approvals, including interactions with health authorities. Demonstrated track record of driving regulatory strategies for the approval of new or revamped manufacturing facilities, supported by strong GMP knowledge and expertise. Hands-on ...