Director Global Regulatory Affairs ** Remote ** Growing Team ** Initial projects in Phases 1&2 ** US and EU Dev.

Reference: CST512

Expiry Date: 03-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Suffolk County
Съединени щати
Remote Working

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Job Description

We are looking for someone who is ready and willing to enhance their Regulatory knowledge and experience, with a small company that is rapidly growing and expanding. There will be lots of opportunities to broaden your expertise and take the lead for US and Global projects. We are offering a great platform for the right person to learn, develop and lead, in a role that is highly visible and key to the regulatory department!”

Location: Fully Remote – HQ in MA.

My client is a fast growing and highly rated biopharmaceutical company, which is building a unique portfolio of innovative, first-in-class therapeutic candidates for patients with rare genetic disorders. Due to the fast growth of its portfolio my client is now hiring a new Director of Global Regulatory Affairs for a role where the initial focus will be on early-to mid-stage development projects.  Reporting directly to the Head of Global Regulatory Affairs, this role will suit you, if you are looking for opportunities to broaden your Regulatory Affairs experience and take the reins for projects (including Biologicals) as the US and then Global lead.

This is the start of a growing team, and your role will cover indications in both the US and EU in Phases 1 & 2, so expect your project activities to be wide ranging and varied.  It’s not essential for you to have covered every aspect of clinical development as there is the expectation that you may want to “grow into the role” and “gain new experiences” from the senior team members around you, but you will need to have worked in development (in either early or late phase) and have experience of working with the FDA and/or EMA.

My client is happy to provide the next phase of learning. So, if you have worked on early development projects and want to move into late phase and filling or have worked on Phase 3 to NDA/BLA and now want to supplement your experience with some early development projects, then my client would be interested in your application.

What makes this role interesting and compelling is the opportunity to lead indications from early development through to NDA/BLA, learning and developing your experience(s) as you go. The expectation here is to bring your energy and creativity as a strategic lead, representing regulatory affairs internally and with the major HA’s, but also learning and developing your experience as you go.

Director Global Regulatory Affairs Major Responsibilities:

  • Act as the primary regulatory representative on the assigned projects
  • Define the company regulatory strategies for the biologic and small molecule programs starting in Phases 1 & 2
  • Lead Regulatory initiatives across the portfolio
  • Represent the company on communications and in meetings with health authorities, assessing impact of new regulations and managing regulatory documents
  • Negotiate with regulatory authority personnel to expedite review and approval of pending submissions as well as respond to queries.

There is a great package on offer and full flexibility to be based remotely (HQ is in MA).

Please, contact me, Theo Moore on US +1-908.348.6714 or via email at Theo@Advtalent.com and I would be happy to discuss the role further and give you more information.

If this role isn’t quite for you but you are open to something new, I would be happy to discuss other roles we have open.

 

To Apply!

To apply for this role, please contact me Theo Moore on US 908.348.6714 or press the red “Apply for position” button. I will support you throughout the interview and on-boarding process!

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