Senior Development Regulatory Center Manager (m/f)

      Novartis

      Unterach am Attersee - vor 1 Monat

      Sandoz
      Development Center

      Unterach / Austria

      Sandoz is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to discover new ways to improve and extend people's lives.

      Senior Development Regulatory Center Manager (m/f)

      Area of Responsibility

      • Contribute as Development Regulatory Center (DRC) Manager Chemistry, Manufacturing and Controls (CMC) expert to technical project teams during product development
      • Ensure alignment across global and local functions with regard to strategy and direction for timely preparation of high quality CMC documentation to support new regulatory submissions for complex new product developments and/or for a portfolio of new product development projects
      • Independently and proactively identify required documentation for submission and coordinate the availability of approved technical source documents in accordance with project timelines
      • Write high-quality CMC documentation according to agreed CMC regulatory strategies, while assuring technical congruency and regulatory compliance, to obtain rapid and advantageous registrations of new products world-wide
      • Prepare CMC responses to health authority questions during product registration
      • Manage/lead DRC related projects or global initiatives
      • Mentor junior team members
      • Assist Head of Regulatory Affairs in annual budget and submission planning
      • Deputize for Head of Regulatory Affairs

      Qualification

      • Academic degree in life sciences (Chemistry, Biochemistry or equivalent area)
      • At least 3 years' experience in Regulatory Affairs (with a focus on knowledge of CMC requirements worldwide and critical evaluation of emerging requirements)
      • Develops and presents strategic regulatory options to internal and external stakeholders
      • Demonstrates strong leadership skills, establishes (cross-functional) teams/relationships and maintains them
      • Very strong communication skills in English, German skills would be beneficial

      Please apply online (Job ID: 242465BR)

      Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, training possibilities and global career opportunities). In accordance with the Austrian collective labor agreement, we have to advise you that the minimum annual gross salary for this role is EUR 44.287-. We are willing to overpay.

      Contact: Jennifer Kriedemann | Recruitment | +44 20 3819 2934