We are an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations.
Job Summary
Essential Pharma seeks a senior leader to oversee global regulatory activities, develop regulatory strategies, and ensure compliance with international regulations.
The successful candidate will be responsible for developing and implementing innovative regulatory strategies globally, ensuring compliance with local and international regulations. They will partner with the business as a strategic advisor to achieve company objectives, including due diligence activities.
This role involves overseeing the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, etc.) to health authorities like the MHRA, FDA, EMA, and others. The candidate will also act as the primary liaison with regulatory bodies, driving communications to maximize the likelihood of timely approvals.
The position requires strong cross-functional communication skills to ensure alignment with regulatory strategy. The successful candidate will lead and build the regulatory team to develop knowledge, skills, and capabilities to deliver the business strategy.
About Essential Pharma
We treat patients in more than 70 countries and are proactive in identifying low-volume, difficult-to-manufacture therapeutic products and late-stage clinical development assets that target rare diseases.
We have a high-impact portfolio of over 300 medicines covering ten therapeutic areas, with a focus on the CNS, gastroenterology, ophthalmology, and rare diseases.
What We Offer
* A competitive salary ranging from £120,000 per annum.
* Agile working arrangements with flexible hours and two days a week at our Egham site.
* An annual leave allowance of 26 days plus bank holidays.
* An enhanced sick pay scheme.
* Enhanced family leave provisions.
* A discretionary annual performance bonus.
* A recognition program with rewards up to £2000 for gold awards.
* Healthcare insurance and pension contributions.
* Lump sum (tax-free) death benefit of four times basic salary.