Expiry Date: 18-05-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
New York County
Executive Regulatory Director ** Lead a team of global strategists ** Above brand role ** Oncology Haematology (Tri-State)
This role reports to my client a VP of Regulatory Affairs and global TA head. The individual is a supportive line manager, who gives you the remit and support to be effective in your role. You will deputise on certain activities for the person.
This is sitting in a global TA regulatory group, managing GRLs and strategists looking after NMEs in both early and late development, including high prioritized assets, and inline products for major label expansion or new indication filings.
That said, this role is above the brand, you will steer your GRLs through mentoring and round tables to identify and drive innovation, identify shorter timelines to file, and develop robust packages for both major filings and FDA and EMA meetings. You will partner with the European and Asia Pac leadership to support the global filings.
This therapy organization is the largest TA in this company, and generates nearly 20 USD Billion per annum, so you are not joining a minnow, it is a top 10 R&D based pharmaceutical company.
The role is a leadership role with headcount, so you exhibit the qualities and approaches you have gleaned over time by climbing the ladder, and feel you are now ready to take on a role which will allow you to develop further, under the support and guidance of an individual and LT with many, many regulatory successes to their merit.
About Your Experience
It is likely you will have worked in both regional and global strategy roles in regulatory, and have managed teams of between 3 and 10 FTEs, either in fuller matrix environments, or as direct headcount.
You will have attended probably many US FDA meetings in your formative years and have co-/led NDA and sNDA submissions, with strong exposure to the EU regulatory framework, ie, have led teams in matrix to file in the regions.
You will have presented to governance or been invited to governance, and will have taken part in cross-department initiatives.
You will know how to generate involvement and the respect of your peers and direct reports, as well as your stakeholders by leading by example, encouraging individuals through coaching and acknowledgment and by identifying opportunities for your people to develop in.
Ultimately, this role is not for the meek minded (there is a lot more in the role which will become evident on application) but we do seek a polished communicator who comes across as a natural people manager (even if you had to put the work in to achieve this).
All applications are in confidence. ADV Talent will ask you to speak with us first before divulging where or who our client is.
To apply, please call either Matt Greig on 908-332-9157 (til 12 pm Eastern) or Roland Schnapka on 908-348-6717 (til early PM) or send a full CV to firstname.lastname@example.org or press the red “Apply for position” button. We will support you throughout the interview and on-boarding experience.
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