Expiry Date: 10-11-2021
Categories Biotech, Pharmacy, Regulatory Affairs
Job Type: Full Time
Regulatory Strategy Leader ** Science-Based, Early Development ** NYC / New Jersey
About My Client
This is a well-known biopharmaceutical company with around 70% of its revenues in Oncology and Haematology, with well-known drugs in market, including mAbs, NCEs, and even new modalities.
The client has hired several individuals who are at Associate Director level, and now is seeking to bring in an experienced Regulatory Director who wants to work at the project level, but is willing to help develop and mentor so of the less experienced individuals.
This role is a translational medicines regulatory expert who wants to manage projects not people, and for someone who really prefers early development as it is in my client’s words, where strategy is really evolved and created. The work-life balance is suitable for people with commitments and you will have a global matrix to support you with your regulatory plans.
Scope of Role
The emphasis is on exploratory early phase development through in INDs, to identify potential efficacy signals and potential indications and target labels (TPPs) for a number of NMEs in parallel. The company does not lack investment budgets and acts on promising data very quickly.
You will be responsible for leading regulatory strategy with your partners in the global project teams, as well as the regulatory sub-teams for your assigned programs, which will include both small and large molecules including drug-drug combinations. This organisation has state of the art systems and processes, CoDx support through a sister team, as well as a global matrix of regional leads and LOC (affiliates) people for you to draw upon. Core markets are primary the US, then Europe and China / Japan. It’s a global role but your US experience is what we are seeking as a minimum.
Experience & Skills
For this role, Oncology is highly desirable, but must haves include prior US FDA experience, especially with any adaptive designs but this could be Oncology, Orphan / Rare Diseases or others, an open, receptive, learning mindset (you will absorb a lot of data), and the experience and passion to think for a broad number of assets with different MOAs. My client strongly prefers a PhD or MD candidate or someone with Masters in a discovery or research discipline, who is committed to working in Regulatory Affairs.
Covid & Remote Working
My client’s policy is up to 50% remote - the options would be in the PA / NJ area or NYC. The 50% can be in spent in any format such as 2.5 days/week or 2 weeks/month in and 2 weeks home and it can flex depending on the person you are reporting to and regulatory key timelines.
Please contact me, Matt Greig, for this role by email to email@example.com or if you would like more information on the role, please call me on 908-332-9157 (including Saturday and Sunday AMs). I will support you throughout the interview and on-boarding experience.
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