Senior Director of Reg Affairs *** Support groundbreaking projects in early stages through submission *** (East Coast Remote or Hybrid)

Reference: JPC556

Expiry Date: 30-06-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

If you are looking for an opportunity to utilize your US/Global regulatory development experience in Cell and Gene Therapy, where you work closely with an impressive (and ex-Big Pharma) senior leadership team in a leading role developing regulatory strategies and pathways for innovative Cell and Gene therapy medicines, then this could be the opportunity you have been looking for.

Our client is a strong, established and reputable Cell and Gene Therapy company committed to delivering life-changing treatments for people battling devastating rare diseases with a high unmet need. Currently they number at around 300 people but continue to grow across the whole organization.

The company is always eager to bring likeminded and enthusiastic people on board, and promise to give you the platform, space and opportunity to achieve your  goals in regulatory affairs. The current members of the regulatory team have impressive filing track records, and are fully aligned when it comes to making a real difference for those who need it the most.

About the role

- You will work as a Senior GRL on US based programs for Rare Diseases, for 2 NMEs in parallel, to bring these NMEs from Ph 1b and 2a into pivotal study. The modality or molecule type is disease modifying and also novel

- You will ensure the development of robust, global regulatory strategies for assigned projects and adapt and/or maintain the regulatory strategy as needed

- You will provide ongoing regulatory guidance and regulatory submission planning to project teams

- You will develop submission plans and timelines in accordance with project goals, lead 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.

About you

- You will have strong US regulatory experience plus knowledge of the EU regulatory framework and be happy working in early development for the next couple of years when the NMEs will reach the final stage

- You will have strong knowledge of eCTD elements and structure and regulatory writing skills, as well as the ability to work independently and thrive in a fast-paced environment

- You will be a dependable and engaging, outside-the-box thinker who can also provide advice and change the consensus based on solid strategies by working with the stakeholders to advocate these.

About the offer

- The role is fully remote for anyone able to work EST hours. You will only be required to be on site for global project meetings or the planning of FDA or EMA regulatory meetings

- The package comes with both annual and joining stock / stock options, as well as a decent performance bonus. The salary rate is very generous and is calculated depending on your level of capability and if you have been a Senior Director already.

To Apply

In the first instance, 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. I am based on West Coast so happy to take calls in the early evening Eastern standard.  ADV Talent will support you through each stage of  the recruitment process