Regulatory Affairs Manager

Regulatory Affairs Manager

Amgen

Zug, Switzerland

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this business critical role you will provide expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

  • Plan and manage local regulatory submissions to Swissmedic in compliance with corporate standards and local legal requirements (e.g. HMG, Arzneimittelzulassungsverordnung AMZV, Verordnung über klinische Versuche in der Humanforschung Vklin);
  • Maintain existing product registrations (variations, renewals, line extensions, manufacturing changes, post-approval commitments), devise and implement local product related regulatory strategies, in compliance with corporate standards and local legal requirements;
  • Prepare and submit new Marketing Authorisation Applications in accordance with local legal and internal requirements;
  • Act as a contact to Swissmedic in fulfilling local marketing authorisation obligations;
  • Maintain and approve local labelling, review promotional material Arzneimittel-Werbeveordnung AWV, Pharma Codex;
  • Ensure regulatory clinical trial submissions to Swissmedic are made on time and meet Amgen’s corporate and local regulatory requirements in Switzerland.

WHAT WE EXPECT OF YOU

We are all different, yet we all use our outstanding contributions to serve patients. What we seek in you as an expert professional are these qualifications and skills:

BASIC QUALIFICATIONS:

  • You posses a Bachelor’s degree and 5 years of directly related experience;
  • You are fluent in German and English, both written and spoken;
  • Experience in Regulatory area;
  • Strong communication and organizational skills;
  • Ability to input effectively on multi functional teams;
  • Ability to anticipate and prevent potential issues;
  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

PREFERRED QUALIFICATIONS:

  • Fluency in French;
  • Regulatory expertise for Switzerland, EU and biotechnology products;
  • Experience in building relationships with regulatory authorities;
  • Experience in defining and implementing policies, procedures and SOPs.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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