OPTION SUISSE ** Regulatory Senior Manager or Associate Regulatory Director ** Gene Therapies for Rare Diseases

Reference: MGU030622

Expiry Date: 04-10-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Basel-Stadt
Switzerland

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Job Description

NOTE: I am hiring for a real innovator, who is developing ATMPs for Rare Diseases, in metabolics, neuro and inherited disorders. These 2 open positions are based in Switzerland, near the German and French borders.

The roles come with relocation package if needed!

My client is a company which has both marketed and development compounds in Europe and the USA and is seeking a highly driven, likeable, regulatory professional to manage both development and lifecycle products.

These 2 new roles have come about because their P2 programs are now entering P3, and they have recently licensed in a new NME which will also go through EU Scientific Advice and P3 design / start up.

We are looking for 2 individuals at Senior Manager or Associate Director levels, who have either:

  • Strong lifecycle management for the EU on clinical, non-clinical, safety, labelling updates (not CMC lifecycle) combined with a good understanding of the EU Regulatory framework.
  • You have a regulatory development background, i.e., in regulatory for P2/3 development, preparation of Scientific Advice meetings, Safety Updates, MAA preparations, ODD, PRIME, ATMPs.
  • You like working in agile focused development teams, which includes interfacing with clinical and stats, as well as senior stakeholders (the company is very flat).
  • You want to be given a mix of development, MAA prep and lifecycle management, regardless of what you have today, you want full project lifecycle experience tomorrow.
  • My client will consider people looking for Director level, for individuals with formative filing skills and achievements!

Package & Benefits

In return for your experience, my client is offering a decent package including sign on RSU stock and options, a high end bonus, and the opportunity to gain some real hands-on experience with Gene therapies.

Relocation

My client is not a Top 10 pharmaceutical company but are willing to consider relocation for the right individual. The quality of life in Switzerland is very good, and salaries are significantly higher in real terms than the EU or UK. Applications are invited from EU Citizens, US or Swiss Nationals.

 

To Apply!

To apply for this role, please contact Matt Greig or Javier Monfort, on +41.41.562.0151 during office hours, or +44.207.801.3386 after hours and early evenings. Alternatively, please send a full CV to CV@AdvTalent.com and we will reply by return. We will support you throughout the interview and on-boarding experience.

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