GENE THERAPY REGULATORY: Senior Managers and Associate Directors ** FULLY Remote

Reference: JM10594

Expiry Date: 31-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Greater London
United Kingdom
Remote Working

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Job Description

NOTE: These roles are UK-based and fully Remote, and can be graded as Senior Manager or Associate Director.

My team and I would like to let you know about 2 positions we have been given, for a Rare Diseases & Gene Therapy company, with existing Marketed Products and 7 NBEs in their pipeline (Viral Vector, RNA).

I am pretty excited about these opportunities because if you are a self-serving Senior Regulatory Manager, who has helped file Line Extensions (Clinical or Label Expansions) and have an interest in Metabolic or Neuro or Orphan Diseases, you can work from home and achieve your first Associate Director grade.

Some people ask me, is my client a real innovator, or do they just buy out companies and IP, and have no research or discovery as such themselves?

Well, this company is the antithesis of this question, the CEO has taken from his own discovery and research labs to the clinic (he is a Geneticist Paediatrician Medical Doctor with PhDs) and has a track history of 8 or so approvals.

The company have their own labs, their own bio pilot site and soon, their own Viral Vector GMP site, this is not a virtual company and the CMO is a real innovator, driven by helping children with significantly rare diseases, often debilitating or critical.

This company basically ticks all the ethical, financial and success boxes!

What will interest you above ad?

  • Work on late phase assets in preparation next year for MAA/BLAs using both the ATMP, ODD and Centralised procedure pathways
  • You will work on 2 or so compound in parallel so the role offers diversity and variety, whether co-preparing a MAA or preparing for SA or Pre-Subs meetings, or preparing ODDs, annual updates
  • You will gain global exposure while working as an EU Lead for your own projects under the direction of high achieving GRLs with a reputation for developing their people
  • Leadership team is accomplished, empathetic and supportive
  • The molecules are brain teasers, the diseases have very high unmet medical need, and the pathways generally fast tracked or adaptive
  • You will have experience that is relevant to the above but, for the main items Ph 3 CTAs, Line Extension / New Indication builds, HA responses, ODDs are the main items.

In return the company offer dependent upon grade, Stock and Stock Options as well as a competitive basic salary and performance bonus. Holidays are above average.


To Apply!

To apply for this role, please contact me, Javier Monfort or my colleague Christian on UK +44 20 7801 3385 or press the red “Apply for position” button. We will support you throughout the interview and on-boarding experience.

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