Director, Regulatory Affairs--Remote
Caligor is seeking a motivated and talented individual to join the Regulatory Affairs team. This position is a key member of Caligor’s Global Access Program (GAP) Division, and is responsible for the evaluation of global access programs from the regulatory perspective as well as providing ongoing regulatory support for clients.
The ideal candidate should have experience in the area of clinical development of small molecules and biologics including IND submissions to FDA and CTA submissions to ex-US health authorities. Knowledge and awareness of the pertinent clinical trial regulations and how they apply to this rapidly evolving pre-approval access field is desired.
The ideal candidate will have a track record of relevant experience gained in an equivalent industry position. Candidates must thrive in a fast-paced, start-up, virtual team environment. Excellent communication, organizational abilities, and independent problem-solving skills are a must. This is a full-time position reporting to the VP of Regulatory Affairs located in the UK, is home based within the US Eastern or Central Time Zones and could involve working outside of normal business hours.
- Scientific degree (chemistry, biology, pharmacy or related, pharmaceutical, or engineering sciences).
- Minimum 8 years regulatory affairs experience in a clinical stage pharmaceutical, biotechnology or Clinical Research Organization (CRO).
- Prior experience guiding and motivating regulatory and development teams; direct experience with regulatory submissions and product development. Prior Account Management experience a plus.
- Oncology and rare disease experience is strongly preferred. Reimbursement experience a plus.
- Self-motivation, good judgment, strong follow up, organizational, analytical, and problem-solving skills; capable of identifying risks; creative and innovative thinker.
- Ability to work effectively with limited directions, guidance and minimal supervision, to set priorities and multi-task to meet timelines in fast-paced and demanding start-up environment, to coordinate with others, and to manage submissions.
- Strong team player, with excellent oral and written communication skills.
- Excellent customer relationship skills including working through high pressure situations directly with clients and their cross functional teams.
- Given the global nature of the business, the ability to work outside of normal US business hours is sometimes required.
- Some travel (international) may be required.
What is a Global Access Program (GAP)? GAP is Caligor’s term for structured sponsor supported programs also commonly referred to as “named patient,” “expanded access” or “compassionate use.” These programs allow for treatment access outside of a clinical trial or commercial setting in a patient’s home country.
GAPs are targeted programs specifically intended for patients who have exhausted all commercially available treatment options, have no ability to enroll in a clinical trial but could benefit from therapies that are still in clinical development. Caligor’s GAP Division was established to provide patients with access to unlicensed medicines across the globe and is dedicated to helping to save lives.