Senior Regulatory Affairs Product Specialist

Job description

📍 Warsaw, Poland – Hybrid (1 day per week in-office) At Theramex we are driven by a clear purpose by improving the lives of women around the world through innovative and accessible healthcare. As one of the fastest growing global specialists in Women’s Health, we combine the agility of a scale up with the impact and ambition of a private equity backed organisation. Here, your work translates into real world outcomes - shaping portfolios, influencing strategic direction, and driving meaningful change for patients. You’ll join a collaborative, high performing team that values expertise, encourages fresh thinking, and empowers people to lead with ownership. If you are motivated by purpose, growth, and the opportunity to make a lasting difference, Theramex offers a place where your contribution truly matters. About you 👤: Advanced experience with practical European Regulatory Affairs, including a good understanding of the following MA lifecycle activities within DCP, MRP and National procedures (preferably also other than URPL): post‑authorisation variations impacting CMC, Safety and Product Information different submission strategies (e.g. single, grouping, SuperGrouping, WorkSharing)...