Job Description

We are recruiting for a very reputable smaller biotech keen to bring someone new on board to gain US/Global regulatory development experience in Rare Disease therapy, where the person will work closely with an impressive senior leadership team in a leading role and a growing company.

This is an up-and-coming company committed to delivering life-changing therapy solutions for people struggling with debilitating rare diseases with a high unmet need.

If you seek room to grow and all you need is the support of knowledgeable executives with proven track records to put your name to breakthrough meds, this is the opportunity you have been looking for!

Your profile:

- To be successful in this role you would be knowledgeable in ICH, FDA and EMA guidelines with strong knowledge of eCTD elements and structure and regulatory writing skills

- You will possess the ability to work independently and thrive in a fast-paced environment

- You will be a detail-oriented team-player able to lead a team with strong analytical and strategic skills

- You will have at least 10+ years of pharmaceutical product development and will be well-versed in regulatory strategy and writing

- You will have proven track record as the primary regulatory author for IND and CTA documents

- You will know how to work collaboratively on cross functional teams, including process development, manufacturing, quality, and regulatory.

Your responsibilities:

- The actionables that come with this Snr Director role involve direct interactions with the FDA and other health authorities to ensure that interactions with regulators are properly communicated to the development team

- Another deliverable would be developing submission plans and timelines in accordance with project goals, leading cross-functional efforts to deliver high-quality submissions, e.g., INDs, CTA and orphan applications

- You will also need to 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

- Lastly, you will manage submission development, developing and/or authoring content as applicable.

The offer:

- The role is fully remote, as long as you can work EST hours. You will only be required to be on site for quarterly meetings or emergencies

- The package comes with both annual and joining stock options, as well as an impressive performance bonus. The salary itself is very generous and is calculated depending on your profile and experience.

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, Theo@AdvTalent.com and I will reply by return.