Regulatory Affairs Manager

Created by: Sandoz
Added: 12.06.2020

Advert description

Job Description

Your responsibilities will include:

  • Preparation of the regulatory strategy for new submissions
  • Timely submission of new products to Swissmedic in agreement with the yearly target
  • Obtain a number of marketing authorizations in accordance with the yearly target
  • Build product maintenance to ensure regulatory compliance
  • Provide regulatory support to the product launch work stream
  • Strategic business partner to Business Development, Quality Assurance, Supply Chain as well as for Global Regulatory Groups (RCCs)
  • Follow trends in the regulatory environment and legislation and assure awareness and alignment within the department, in order to meet future efficient requirements on time

Minimum Requirements

  • Pharmacist or natural scientist preferably with medical background
  • German (proficient), English and French (desirable) and Italian (an asset)
  • Intermediate to senior level (at least 2-3 years Regulatory experience); experience in Biosimilars of Advantage

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Master's, Other
Level of Experience 2-5 years

Location

Switzerland, Europe
Rotkreuz