<br/>    <div> <div> <p>Direct message the job poster from Skilled Recruitment Solutions GmbH</p> <div> <a href="https://ch.linkedin.com/in/meike-engelhard-[phone hidden]"> <span> Meike Engelhard  </span> </a> <div>  <h3> Meike Engelhard  </h3> <h4> Lead Recruitment Consultant bei Skilled - Recruitment Solutions GmbH </h4>  …

Regulatory Affairs Manager

Strategy &amp; Interface: Define EU regulatory pathways and lead all formal interactions with the EMA and NCAs.
Submissions: Oversee the end-to-end delivery of IMPDs, PIPs, Orphan Drug Applications, MAAs , and variations.
Scientific Advice: Lead the preparation and execution of regulatory meetings and briefing packages.
Compliance &amp; Labeling: Ensure EU labeling aligns with the Company Core Data Sheet (CCDS) and regional requirements.
Global Leadership: (When applicable) Own global regulatory functional plans, maintain the CCDS, and lead cross-functional regulatory sub-teams.
Business Support: Provide RA expertise for due diligence and business development activities.