Global Regulatory Lead position for exciting programs in Neuro *** Rare Diseases ** *Remote

Reference: JPC558

Expiry Date: 30-06-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

Apply for position

Job Description

This is a great opportunity to join a strong Cell and Gene Therapy company with a collaborative and energized environment, a good pipeline, strong and passionate leadership and good data on their projects.

Our client is an innovative drug discovery and development biotechnology company with a pipeline of indications in rare diseases. The organization has a growing pipeline of NMEs in early development, with more in pre-clinical and all of their gene therapy indications originate from their innovative discovery and development platform.

They are now seeking a Senior Director grade, Global Regulatory Lead, to manage their early development indications across several TA’s. The Global Regulatory Lead will be responsible for leading and ensuring sound regulatory strategies to secure approvals of the early development portfolio, with the emphasis on the gene therapy programs.

The role will be responsible for developing long and short term planning of regulatory projects that align with the company’s gene therapy business plan and developing strategies to ensure effective achievement of business objectives. You will have internal corporate level influence, and externally, will interface with outside regulatory agencies, corporate partners and vendors in regard to development, regulatory, and registration strategies.

The culture here is engaging, caring, supportive and friendly, with a leadership team that displays agility and strategic thinking and planning. The Executive Team have thrived in their careers and have decent track records on either discovering, developing or commercializing drugs. Our client is financially secure and has a number of lucrative long term collaborations already in place, so they can confidently continue with their plans for growth for both people and pipeline.

Key competencies

  • Experience utilizing leadership techniques to drive a team through the stages of NME development
  • Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
  • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to the senior leadership team and other governing bodies
  • Ability to broadly represent department functions on project teams in a matrix organization
  • Demonstrated ability to coordinate global activities.

We are looking for a strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals, who is able to communicate opinions, facts and thoughts with clarity, transparency and honesty.

If you are interested in applying, or wish to hear more, please contact me, Theo Moore on US +1.587.216.9302 or my colleague, Ivan Nash or +1.908.378.8980 or send a full CV to me, and I will reply by return. I am happy to take calls in the early evenings for both Eastern and Western standard time. ADV Talent will support you through each stage of the recruitment process for this role.