Regulatory Affairs Manager, Innovative Products

Location
Lugano
Salary
£46236 - £100178 per annum + Negotiable
Posted
Aug 16, 2018
Closes
Sep 15, 2018
Ref
MB/87903/4494
Contact
Matt Beedle
Jobseeker Type
Professional
Organization Type
Clinical Practice
Contract Type
Employee
Hours
Full Time

Regulatory Affairs Manager, Development, Strong Pipeline and Established Products, Opportunity to be involved in FDA submissions, Lugano Switzerland, Global Team

Looking to further expand your responsibilities in pre-approval submissions? Want to be involved in a growing business with strong finances?

I am working with a highly innovative pharmaceutical company who are approaching a number of key approvals over the next 2 years. Due to this, we are looking for an experienced regulatory professional to help lead new portfolio products covering PIPs, CTAs, CMC and scientific advice. Key points that make this role attractive are that the RA team shares both pre and post approval activities. Because of this, you will get a mixture of tasks across commercial regulatory as well as developmental. In addition to this, the company currently have strong revenue streams to back up their impressive future pipeline, given this, it is an exciting time to join and no doubt there will be many new projects in the future! If this was not enough, the company also have a good reputation for providing a good work-life balance and are committed to keeping this while still developing into a growing corporate business.

If you could be interested in 'principle', then please contact me.

Key responsibilities:

  • Lead regulatory strategy and processes for certain portfolio products
  • Input towards areas such as scientific advice, HA meetings, CTAs, PIPS and CMC
  • Involvement in LCM activities
  • Work as part of the general EU/FDA and international regulatory affairs team

Key requirements:

  • Fluency in English
  • Over 3 years experience in regulatory affairs for pharmaceuticals
  • Experience in EMA Rx submissions for pre-approval
  • Life science degree
  • Currently located in Switzerland or Europe

For a confidential discussion about regulatory affairs, or to apply, then send your CV to m.beedle@nonstop-recruitment.com or call me, Matt Beedle, Regulatory Affairs Consultant for Switzerland on +41435 080817. For regular job updates and market information please join the Switzerland regulatory affairs linked-in group. https://www.linkedin.com/groups/4550988

I am a specialist headhunter(recruiter) for regulatory affairs in the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on the Swiss regulatory affairs market as well as ATMP(Advanced Therapeutics) and biological regulatory professionals worldwide. Please refer to ch.linkedin.com/in/regulatoryaffairsswitzerland for references.

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