Regulatory Manager

  • Contract type Permanent Position
  • Place
    Aesch BL
  • Reference manager-60985-547997
  • Start date ASAP/By arrangement
  • Sector Chemistry & Life Sciences
  • Publication date 12.05.2022
  • Apply

Mandated by our client, we are looking for a Regulatory Manager. This person will be responsible for managing and coordinating regulatory and strategic activities to company submissions (Pharma and IVDD, IVDR). This position will report to Head of Quality & Regulatory.

Regulatory Manager

Your assignment

- Provide regulatory and strategic management to company submissions (Pharma and IVDD, IVDR)
- Liaison with Regulatory Authorities (EU, US, China, Japan)
- Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide
- Responsible for development and implementation of the Regulatory Strategy and Risk Documents
- Provide regulatory and strategic input on: development concepts and documents (e.g. dev plan, CTA/IND, briefing books, dossier documents); clinical study protocols and protocol amendments
- Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.
- Comply with applicable SOPs, GOPs and WIs

Your profile



- BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Alternatively several years of regulatory or other relevant industry experience
- Fluent English required (oral and written)
- At least 3 years of relevant regulatory experience in Pharma and /or IVD
- Good understanding of regulatory requirements for drug development and IVD, clinical studies, dossier filings worldwide
- Experience in HA negotiations in different regions (EU, US, China, Japan)
- Strong interpersonal skills, team player

   

Interested?

We look forward to receiving your application via the online application form.

About Manpower
Manpower Switzerland offers its customers more than 55 years of experience in the recruitment, selection and placement of permanent and temporary staff, as well as in HR solutions. Its network of 50 branches active in all linguistic regions, 20,000 temporary staff, 1,500 permanent placements and over 5,000 clients – including small, medium and large companies – in all sectors of industry make Manpower one of Switzerland’s leading providers of workforce management solutions.
 
Our 3 promises
“We are passionate about what we do. This passion is a motivating and driving force, ensuring excellent placement opportunities for you.”
“We care about the people we work with. Including you. That’s why our collaborations are based on trust.”
“We take on our responsibilities. For you, that means security and exciting prospects.”
 
 

I'd like to apply

Your Manpower consultant
Luciana Sardo

Recruitment Center Zürich
Schaffhauserstrasse 343
Zurich

T: +41 58 307 29 60



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