** Remote ** Director Global Regulatory Affairs ** Early-Stage dev. role with a clear pathway to Snr Director!

Reference: CST512C

Expiry Date: 17-01-2023

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
United States
Remote Working

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Job Description

Location: Remote with company HQ based on the East Coast, Great Boston, MA

Our client is a small, dynamic, and expanding Global Bio-Pharmaceutical company with a solid and stable background, an established leadership team and a positive financial position. They are currently in the middle of expanding and growing in a number of areas as they go from innovative and exciting start-up to now being an established R&D company with sites in both the US and Europe, with a nicely developing pipeline of NME’s in Phases 1&2.

For the next wave of company growth and development, they are recruiting a new Director of Global Regulatory Affairs to report directly into the Head of Global Regulatory Affairs. This is a new position and is seen as a key role in providing the regulatory strategy for the NME’s in development.

This position will be the lead US based regulatory person for the organization, but the team is expanding with a number of new positions planned for 2023, as the pipeline continues to grow both organically and with new proposed indications and partnerships in discussion.

My client is seeking someone strong in US regulations/guidelines for drug or biologic products, who wants an expansive role, where there will be strategic opportunities to deepen their RA career in a position where there is visibility to both the development teams and the Executive leadership team. 

You will be representing the company on communications and in meetings with health authorities, assessing impact of new regulations, managing regulatory documents, negotiating with regulatory authority personnel to expedite review and approval of pending submissions as well as responding to queries.

Excellent quality, time management and oral/written communication skills are required, as is the ability to work in a collaborative, cross-functional team environment and with both in office and remote team members.

Activities:

  • Act as the primary regulatory representative on the assigned projects and lead Regulatory initiatives across the portfolio
  • Oversee all regulatory matters and executes the strategy to ensure the organization complies with applicable regulations
  • Represent the company on communications and in meetings with health authorities, assessing impact of new regulations and managing regulatory documents
  • Creating and driving RA deliverables and ensuring that phase-appropriate and compliant RA applications are submitted globally

Requirements:

  • Thorough knowledge of FDA drug and biologics regulations, experience with regulators internationally is a plus and EU regulatory experience preferred
  • Familiarity with ICH guidelines regarding oversight of development programs
  • Experience working on project teams is required.  Candidates should be a self-driven  with excellent skills in building working relationships with internal and external stakeholders
  • Experience with development of Regulatory processes, procedures, and/or templates to guide RA development
  • Experience in all aspects of the clinical development is desirable (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3 and Commercial/Licensure), participation in multiple project teams, development of quality strategy and discussions with the applicable Health Authorities are key expectations and requirements of the position

If you are looking for a role with a small company that is expecting to expand, with a strong executive team, indications with promising data, where you will operate as the lead Regulatory representative on your projects, then this could be the role for you.

 

To Apply!

To apply for this role, please contact me Theo Moore or Roland Schnapka on US 908.348.6714 or send your CV to CV@AdvTalent.com and we will respond to you immediately with details on this role. We will support you throughout the interview and on-boarding experience.

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