Vice President Regulatory Affairs ** US Southern States ** Relo Offered ** R&D Based Bio-Pharma Co (code: 28619A)

Reference: MG280619A

Expiry Date: 30-11-2019

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Fulton County
United States

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Job Description

Vice President Regulatory Affairs ** US Southern States ** Relo Offered ** R&D Based Bio-Pharma Co

You might have studied and grown up in the Southern States and have been looking for a role which can bring you back to these States (think south of Maryland), as we have a choice of 2 locations. The role is a leadership role, of people, regulatory oversight, and regulatory excellence in FDA and HC liaison. It is for an individual who can bring together all the teams to drive performance, strategic thinking and innovation in a mid-size cap R&D based company

The company is multi-TA and has several programmes in Ph2/3 and major lifecycle and operates a GRL model. You will with your co-partner in Europe (who has a near identical role but on a European focus) by working closely with the business, to hone the thinking behind strategy and influence decisions by partnering with R&D. The position brings with it:-

  • Accountability & oversight for North American regulatory affairs including US first line and supplemental submissions through your teams (which have Team Directors and GRLs) – you will have previously managed more than 20 people to be eligible for this role!
  • Actively manages and aligns with the business for issues and risks, working closely with other senior leadership teams and functions
  • Oversight and management of the regulatory sub teams excl. CMC, publishing and RIM but including regulatory sciences, strategy labeling, Ad Promo, Policy and Intelligence
  • Oversight and planning for budgeting, resourcing, recruitment, personnel development, performance and motivation
  • Support for due diligence, business development, and licensing
  • Coaches and mentors direct reports as well as the GRL and up and coming US RLs
  • Supports or leads major change management and process change initiatives.

In return for your participation, my client can offer a significant executive level salary, including stock based LTI and bonus scheme as well as a full house purchase / sales relocation. The company will consider for the right individual leveraging out your current stock plan.

 

To Apply!

To apply for this role, please contact Theo Moore on 855.505.1382 or send a full CV to Theo@AdvTalent.com and I will contact you by return. Please note, we can arrange calls on Saturday AMs if this is easier for you, please email me and we can find the best time to connect!

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