Are you a US Regulatory Liaison and want to gain Global? Remote or Relocate!

Employer
Advanced S&S (USA)
Location
RTP Area, NC, USA
Salary
On Application
Closing date
14 Oct 2020

View more

Discipline
Regulatory Affairs, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
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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!

This role is assigned to me, Matt Greig, so please send your CV to CV@AdvTalent.com, or contact Matt Greig or Octavian Dinca on US toll free 908-332-9157 or within Europe call +44 791 867 9405 I do take calls on Saturday and Sunday AMs (US time), as well as normal office hours!

About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our team knows our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

Contact us today to see how we can help you, make that next career move on

+44 20 7801 3380

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8, Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +1 855-505-1382
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