Senior Regulatory Affairs Manager
Product Dev SZ
Unterach am Attersee, Austria
vor 24 Tg.

Job Description

  • Contribute as Development Regulatory Center (DRC) 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 Chemistry, Manufacturing and Controls (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
  • Minimum requirements

  • Academic degree in life sciences (Chemistry, Biochemistry or equivalent area).
  • At least 5 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
  • 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 advise you that the minimum annual gross salary for this role is EUR 47.

    312,58. We are willing to overpay.

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