** Snr Director of Reg Affairs ** Become the GRL for projects in early dev. ** Fully remote **

Reference: JPC568

Expiry Date: 31-07-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

Apply for position

Job Description

- Are you a passionate professional with proven track record in team-management and as the primary regulatory author for IND and CTA documents?
- Are you well versed in regulatory strategy?
- Are you knowledgeable in FDA, ICH, and EMA guidelines?
- Are you someone who knows how to work collaboratively on cross functional teams?
- Do you have 10 or more years of pharmaceutical product development?

If the above describes your profile, you would be happy to hear that our team is recruiting for a very reputable and financially sound biotech keen to bring on board a new GRL (Senior Director). The role will let you develop your experience in Neuro programs and products targeting Rare Diseases.

The knowledgeable and involved executives will be right by your side, but providing you with enough room to grow, as you oversee the progress of life-changing therapy solutions in their expanding pipeline.

As a Senior Director:

- You will handle direct interactions with the FDA and other health authorities, to ensure that their requirements and the company’s data are communicated accurately and on-time
- You will also be in charge of the development of submission plans and timelines, making sure that all project goals are met and driving the determination of your team towards high-quality submissions
- Lastly, you will be expected to effectively communication with team members, senior leaders, and stakeholders on the objectives, risks, mitigation, and current status associated with all your projects.

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 – a generous salary, annual bonus, joining stock options, and an impressive performance bonus.

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.