Regulatory Affairs Therapeutic Area Head
3 weeks ago
CT19 is a pioneering European biotech organisation focused on developing cutting-edge therapeutics for rare diseases. With a strong track record of FDA success and a diverse pipeline of assets, we are committed to bringing innovative treatments to patients with unmet medical needs.
Job Title: Senior Director Regulatory Affairs, Therapeutic Area Head
Location: UK (remote working with international travel)
Salary: £120,000 - £180,000 per annum
About the Role:
This is an exciting opportunity to join our team as Senior Director Regulatory Affairs, Therapeutic Area Head. You will be responsible for ensuring regulatory approval across a diverse pipeline of assets, working closely with senior stakeholders. With experience in marketing applications to FDA and EMA, rare disease & orphan drug experience, people management, commercial strategy and product portfolio oversight, you will make a significant impact.
Key Responsibilities:
- Ensure regulatory approval across a diverse pipeline of assets
- Lead a small team of Regulatory professionals
- Make strategic decisions for the direction of the portfolio
Requirements:
- Experience of marketing applications to FDA and EMA
- Rare disease & orphan drug experience
- People management experience
- Commercial strategy experience
- Product portfolio experience
- A clear passion & motivation for rare disease treatments
What We Offer:
A competitive salary of £120,000 - £180,000 per annum, depending on experience, plus benefits and opportunities for career growth.
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