Senior Director of Regulatory Affairs for Orphan Diseases
4 days ago
CT19 is a leading European biotech organisation dedicated to developing novel therapeutics for rare diseases. Our portfolio ranges from preclinical to approved products, with multiple new indications currently being explored. We are passionate about bringing innovative treatments to patients with unmet medical needs.
Job Description:
Senior Director Regulatory Affairs, Therapeutic Area Head: This role involves playing a pivotal part in ensuring regulatory approval across a diverse pipeline of assets. You will lead a small team of Regulatory professionals, providing them with direction & motivation, and making strategic decisions for the direction of the portfolio. 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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