Regulatory Technical Manager

Swiss Franc53 - Swiss Franc63 per hour
  1. Permanent
  2. Project Manager
  3. Switzerland
Basel, Switzerland
Posting date: 15 Aug 2023
56050

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Proclinical are recruiting for a Regulatory Technical Manager for a pharmaceutical organisation. This role is on a contract basis and is located in Basel.

Responsibilities:

  • Accountable for preparation and upkeep of CMC documentation in internal document management systems and assist with associate actions.
  • Handle regulatory changes throughout the product life cycle.
  • Serve as a representative PTR on any other cross-functional teams, advise cross-functional teams regarding regulatory needs and collaborate with diverse partners and personalities.
  • Partake in driving effectiveness by simplifying, trying new wats and cutting out waste.
  • Assist the technical regulatory division on the implementation of proposal-linked and administrative actions for international technical registrations.
  • Suggest methods for earliest possible approvals of clinical trials applications.
  • Guarantee regulatory compliance together with both local and international technical functions and examine technical change records for regulatory impact.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to a degree level in a scientific field, though an advanced degree would be advantageous.
  • Familiarity with technical regulatory affairs, with profound knowledge on national and global regulations and biotechnology.
  • Capable of handling projects.
  • Communication skills both verbally and in writing.
  • Fluency in the English language with knowledge in German would be beneficial.
  • Computer literacy.
  • Works well in teams.
  • Able to work in a diverse and changing, international setting.
  • Capable of prioritising workload.
  • Attain an open, curious and willing manner to explore new ways of working.
  • Ability to take risks.
  • Capable of making own decisions, assume ownership and resolve issues.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 0789542 or p.duvall@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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