Global Regulatory Leader position - Early Development focusing Neuro and Rare Disease indications – Fully Remote - East Coast USA

Reference: JPC560

Expiry Date: 31-07-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Are you looking for an opportunity to grow your global regulatory development experience in Cell and Gene Therapy for Rare Diseases?

Are you considering working for a smaller biotech, where your contributions are instantly recognized, and your ideas turn into a reality with the support of an ex-Big Pharma senior leadership team?

Do you want to put your name in a key leading role developing regulatory strategies and pathways for innovative C&G therapy medicines?

If the answer is yes - then this the position you have been looking for!

Our client is a very reputable and financially stable C&G Therapy company committed to delivering novel treatments for people battling devastating Rare Diseases. They have great data readout and are eager to grow their team by bringing more likeminded and enthusiastic people on board.


What you will be expected to handle


- You will be responsible for providing global regulatory leadership, strategy, submissions oversight and maintenance on US based programs for Rare Diseases, for 2 NMEs in parallel, to bring these NMEs from early dev into pivotal study

- You will develop timelines in accordance with the company’s project goals, leading cross-functional efforts to deliver high quality submissions, e.g., INDs, CTA, orphan applications

- You will also effectively communicate with internal and external team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various projects.


What the company is looking for


- To thrive in this role, you would be a highly-skilled, ethical, and exceptionally detail-focused professional skilled in managing and leading full-spectrum global clinical trials and regulatory submissions, experienced in conducting research to direct regulatory strategy, and working collaboratively within the FDA, EMA, and other Health Authorities

- You would be a forward- thinking and practical leader skilled in providing regulatory guidance, mentorship, training, and direction to global clinical and regulatory professionals. You would have demonstrated success in supervising Clinical Operations and Global Regulatory Teams on all matters for trials including protocol development, execution, and management, and global regulatory submissions

- You will possess extensive working knowledge and solid understanding of regulatory science, research tools, methodologies, maintenance, and all clinical regulatory issues related to CTA/IND submissions.


What the company can offer


- The role is fully remote, so you can be based anywhere in the US, as long as you can work EST hours. You will only be required to be on site (MA, USA) for quarterly meetings or the planning of FDA or EMA regulatory meetings

- You will receive both annual stock and joining stock, as well as a performance bonus. The salary rate is very generous and is calculated depending on your experience, track record, and whether you have been a Senior Director already


To Apply


Please contact me, Theo Moore or my colleague, Ivan Nash on US +1.587.216.9302 or +1.908.378.8980 or send a full CV to me, and I will reply by return. ADV Talent will support you through each stage of the recruitment process.