Director, US Regulatory Affairs
Our client is a global biotechnology company. They have asked us to assist them in their search for a Director, US Regulatory Affairs.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Collaborates with the team to represent the US Business and integrates US strategies into global strategies as they are developed.
- Participates on Product Cross Functional Team as appropriate.
- Acts as key contact for FDA on product(s) and with direct FDA interaction.
- Ensures messages from FDA are properly conveyed to the business after assessing the feedback and outlining next steps.
- Functions as key contact for internal research, development and business partners on product(s).
- Directs US product labeling, working with the Global Regulatory Lead to ensure core label changes are appropriately expressed in US product labeling.
- Partners with cross functional teams.
- Works with Regulatory Operations for IND, NDA, and BLA submissions to FDA.
- Working with the GRL, ensures core label changes are appropriately conveyed in US product labeling.
- Represents Regulatory on due diligence assessments of new business opportunities as required.
- Provides mentorship to more junior regulatory staff.
- Represents company at industry work events and attends public meetings.
- Requires undergraduate degree in a scientific discipline. Advanced degree preferred.
- Must have regulatory affairs experience having led health authority meetings (FDA).
- Experience with neurology late stage development/marketed products ideal preferred.
- Great leadership skills with high emotional intelligence is required.
- Must be a great team player with strong verbal and written communication skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.