Expiry Date: 28-02-2021
Category Regulatory Affairs
Job Type: Full Time
Are you a US Regulatory Liaison and want to gain Global? Remote or Relocate!
This is a role with a global mid-sized biopharma company with four disease areas with nearly 100 years history and track record of bringing new medicines to market. Not a top 10 pharma global companies, but they are fast moving/high-growth, and much more lean and agile than larger companies and show sustainable growth in all the core regions.
Note: This role can be based remote during Covid, and possibly after for compelling candidates! This role is graded Director or Associate Director!
My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during Covid outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns. The role is in North Carolina, and comes with full support for relocation, a package of measures for compelling candidates to buyout an existing stock plan, and some support for co-location or remote depending upon your capabilities and track record.
About this Opportunity
You have US or US & international regulatory experience specifically for major lifecycle submissions so other country or US first NDAs, s/NDAs, Follow Up Measures, and want to move into a GRL position and be the single accountable person for the global including the US and EU?
You feel you are ready to step up from either an US RL role to a GRL one, or find the Director grade attractive and believe you are ready for this!
You want to work in a mid-sized company where you can be visible, accountable, and useful; you want to develop and coach your regional Liaisons and report to a Commercial PL not a regulatory head.
Do you want to join an organization that invests in its people and where the GRL sits with development/medical/commercial counterparts and where you will gain exposure to non- regulatory commercial and clinical team objectives?
You want to be in a team which is supported and visible! Where there are career paths for you to grow into, in a company where GRLs have moved into commercial, development leading and team management positions, in and outside of the regulatory function.
Your Background & Experience
You have a regulatory track record assisting and leading on NDAs/sNDAs and exposure / direct experience of other international markets.
You have experience working in a cross functional environment with a demonstrated competence in people management together with a knowledge of interacting with and negotiating with health authorities, including milestone meetings.
You know how to translate a concept into a regulatory plan, and how to work with your subteam to support filings and lead negotiations during the agency review process.
Package & Benefits
You will either be self propelling and can show you can work effectively remotely with often visits to HQ, or you will ultimately be happy living / working in the North Carolina area, and are willing to relocate (my client will support this financially) together with annual package that includes a Xmas shutdown, a strong performance bonus, stock plan and full healthcare.
To apply for this role, please press the red “Apply for position”, or contact Octavian Dinca or Matt Greig, on US number 908-332-9157, or if you are dialling from Europe, please call UK number +44 207 801 3386 - we take calls from 7 am Eastern US time to 4.30 pm daily as well as Saturday and Sunday AMs.
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