Director Global Regulatory Affairs – Early Development role in Rare Diseases – Remote (HQ on the East Coast)

Reference: CST512A

Expiry Date: 07-12-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Middlesex County
Съединени щати
Remote Working

Apply for position

Job Description

Location: Remote (HQ on the East Coast)

We have an exciting opportunity for a small, friendly, and dynamic Biopharmaceutical company, with a strong and established leadership team who are building a unique portfolio of innovative, first-in-class therapeutic candidates for rare diseases within the therapy area of hematology.

This organization is young, but they already have a global footprint with offices in Massachusetts and Central Europe and they are currently initiating several clinical trials with both biologic and small molecule programs. You will find this a great opportunity to drive the process from early development, formulating the ideas and putting together the plans for future global registrations for a number of indications across their growing (and highly rated) pipeline.

As the Director Global Regulatory Affairs (Reporting into the Head of Global Regulatory) you will act as the primary regulatory representative on the assigned projects, defining the company regulatory strategy for the biologic and small molecule programs, drawing from experience and creative, reasoned thinking to maximize opportunities and mitigate risks.

This is a full-on early development role, where you are taking the creative leadership for indications in Phases 1 and 2, representing the company on communications and in meetings with health authorities, assessing impact of new regulations and managing regulatory documents. You will also be negotiating with regulatory authority personnel to expedite review and approval of pending submissions as well as responding to queries.

Ideally you will enjoy working in early-stage development and have in depth knowledge and understanding of applicable US regulations/guidelines for drug or biologic products. Candidates should be self-driven with skills in organization, building working relationships and a positive pro-active communication style.

Responsibilities:

  • Collaborating with stakeholders to make science-driven, phase-appropriate, and risk-based decisions, and proactively identify gaps and design mitigation strategies
  • Interacting effectively with functional leads in CMC, nonclinical, clinical, and other stakeholders. The individual will be asked to participate in program teams in support of the RA function, liaise with third parties representing RA, and be responsible for the notification and inclusion of the most appropriate individuals within the company to address priority issues
  • Working across all aspects of the clinical development (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
  • Creating and driving RA deliverables and ensuring that phase-appropriate and compliant RA applications are submitted globally
  • Authoring, reviewing, and/or approving documentation, regulatory strategies, and RA global content for applicable submissions/programs.  Provide appropriate RA oversight of programs as well as coordinate and manage global RA submissions to ensure compliance to regulatory expectations and adherence to relevant with internal Standard Operating Procedures (SOPs)

On offer is very competitive package at Director grade, including strong basic, bonus and stock, but you will also have the opportunity to work remotely or if you prefer, from offices in Cambridge Massachusetts.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, on US 908-348-6714 or send us a copy of your resume to cv@advtalent.com. We will support you throughout the interview and on-boarding experience!

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.