Expiry Date: 29-06-2021
Category Regulatory Affairs
Job Type: Full Time
Global Regulatory Associate Director CoDx’s & DigiMeds - Oncology Precision Meds NJ/NYC/PA
About my Client
This is a role with a company part of the Top 10 global biopharma companies with >100 years history which is one of the big 3 in Oncology and with a focus on Precision Meds used in combination with Immuno-Oncology and their other therapeutic areas, and a track record of bringing new medicines to market while having one of the most innovative pipelines in the industry.
The team is managed by a considerate, capable and mindful Vice President, who is building up the team on two sides, with Oncology and Precision Meds for clinically useful biomarkers, and with their Digital Medicines for med ed, adherence, and other patient-centric innovations, this regulatory role is one of the key bridges between the Clinical Development, Therapy Regulatory and Precision Meds teams.
Note: My client offers Digital Hiring and On-Boarding using Video Conferencing and the successful candidate will be inducted and trained remotely. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal office working returns!
About this Opportunity
Are you excited by a strategic role that allows you to drive and shape scientific innovation? In this role, graded as Associate Director you will act as the CoDx RA strategist and a team member sitting alongside Global and US Regulatory Therapy Leads to support Oncology, Neuro, Immunology, Genetic and Cardio medicines development by developing the RA plans for the CODXs and / or accompanying Digital Medicines solutions with oversight for any necessary Regulatory submissions.
The role is global and this is a great opportunity for an experienced CODx or Digital Medicines regulatory professional. You might have gained your regulatory experiences with an IVD company supporting Oncology development as a vendor or in-house with a Biotech or Biopharma, in order to steer and bridge the two-parallel development workstreams. Alternatively, you might be working on Digital Medicines and want to broaden your experiences. Lastly, you might be working with a Regulator and now want to come over to industry.
You will have already provided tactical and operational support as well as coordination of associated IVD or Digital submissions to the US FDA or other health authorities. You will be a capable communicator, able to work well in matrix teams, with your own accountabilities and deliverables.
You will want a career environment where stead progress is encouraged and understand the idea that development comes with merit and aptitude.
My Client Offers in Return
A high-end basic salary as well as a high-performing stock plan, bonus scheme and medical insurance with shorter vesting. A full relocation is available post-Covid, whether you own a house or rent one, and you can be hired and on-boarded at home in the meantime. My client will buyout a certain amount of stock or performance bonus!
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