About this role

  • Posted on

  • Location

    Bedford, Massachusetts

  • Salary

    $180000 - $220000 per annum

  • Type

    Permanent

  • Division

    Pharmaceutical Regulatory Affairs Jobs

  • Reference

    BB - 15641.1_1609847258

  • Start date

    ASAP

  • Managing this role

Executive Consultant

Brieuc Baeckeroot

+44 203 8540 263

brieuc.baeckeroot@xplorelifescience.com

Source Group International GmbH, Bosch 106, 6331 Hunenberg, Switzerland

Description

Joining a Biotech is always exciting, and has always some challenges to offer.
Here the Biotech already has 2 products on the markets which give the company stability, and the capacity to project themselves.

You will join an environment that will give you that excitement to work on new products and bring them on the market. You will also work on the product already register to reach new markets.

The chance to be part of a company at that stage is a lifetime opportunity that we see rarely.

Your tasks:

  • Develop and put in place the Global Regulatory Strategy for the products in development as well as the product already on the market
  • Interactions with the Health Authorities: US & Global Health Authorities
  • Responsible for the Pre-Approval submissions: PMAs, 510ks, international dossiers and/or CE technical files; INDs, NDAs, MAAs, NDS, and global CTAs.
  • Management: One report and more (small team)

Your experience:

  • 10+ years’ experience in regulatory affairs in the pharmaceutical industry with 3/5 years experience in a managerial role
  • Experienced in developing multiple products (Combination, Medical device OR/And Drugs) from the development to the commercialization.
  • You have been working on combination products

Willing to know more, having some questions? Do not hesitate to contact me.

Contact:

Feel free to reach me even if the position is not exactly what you are looking for.
Please share it with your network or any person you think you might be interested in.
You can send me your CV, Resume in word format with your contact details through the link OR you can contact me on Linkedin.

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