VACANCY: REGULATORY AFFAIRS OFFICER

ANDERMATT PHP is looking for a REGULATORY AFFAIRS OFFICER to join our team in the REGULATIONS department.

PURPOSE OF THE POSITION

The Regulations department spans Regulatory Affairs, in which specific projects aim to register biological products manufactured by Andermatt PHP in different global regulatory areas, and Quality Assurance, in which limits and requirements from registrations are brought into the company’s manufacturing process.

A regulatory affairs officer carries out registration projects on time and reports on KPIs to the wider team, including Product Management. This person would also be required to work with Operations in enforcing regulatory requirements. Regulatory requirements are in a constant state of revision, and this person must keep up to date with current requirements.

KEY RESPONSIBILITIES

  1. Track assigned registration projects.
  2. Set up laboratory studies as required for regulatory projects on biological products. Technical knowledge, experience, or ability to learn how to structure a study plan within scientific and regulatory requirements is required.
  3. Feedback information to Operations.
  4. Work with the team in QA to continuously improve processes.
  5. Communicate with the internal team at Andermatt PHP and the external team within the Andermatt Group.
  6. Using Microsoft based programs (Teams, OneNote, Excel, Sharepoint) to organize and share information.

SKILLS REQUIREMENTS

  • Ideally a background in science, including agronomy, chemistry, biology, or related fields. Strong technical knowledge required (laboratory based).
  • Excellent communication, numeracy and computer literacy skills.
  • Excellent organisational skills.
  • Willingness to work in a team but also capable of independent work.

QUALIFICATIONS

Minimum of a post-graduate qualification in a biological or agricultural related field.

Should you meet the above criteria, please send your current CV (not more than 3 pages) with motivating letter to hannah.heine@andermatt-php.co.za.  If you do not hear from us within 14 days of submitting your CV, please consider your application unsuccessful.

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