Global Head of Regulatory Affairs

2 weeks ago

Egham, Surrey, United Kingdom Essential Pharma Full time
{"Job Title: Global Head of Regulatory Affairs

Job Summary: Essential Pharma is seeking a highly experienced Global Head of Regulatory Affairs to lead our regulatory strategy and ensure compliance with global regulations.

Key Responsibilities:

* Develop and implement regulatory strategies to ensure compliance with local and international regulations
* Lead the creation and execution of regulatory plans across global markets
* Oversee the preparation, submission, and management of regulatory documents to health authorities
* Collaborate with cross-functional teams to ensure alignment on regulatory requirements
* Act as the primary liaison with regulatory bodies and manage communications
* Stay updated on global regulatory changes and ensure compliance throughout the product lifecycle
* Identify potential regulatory risks and develop mitigation strategies
* Lead and mentor the regulatory affairs teams

Requirements:

* Extensive experience in regulatory affairs within the pharmaceutical industry
* In-depth understanding of regulatory requirements and guidelines from agencies like the FDA, EMA, and others
* Experience of leading small teams across multiple countries and time zones
* Deep GxP knowledge

What We Offer:

* Competitive salary
* Agile working
* Healthcare insurance
* Pension
* Life insurance
* Enhanced family leave
* Enhanced sick pay
* Annual leave
* Discretionary annual performance bonus
* Recognition program

About Us:

Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases.

We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the group's second product for treatment of a rare disease, and the first development-stage asset in our portfolio.

Our UK Operations team is comprised of 60 people, based out of our Egham, Surrey office, five minutes' drive from Egham Train Station situated on the Thorpe Industrial Estate. We also have colleagues based in Malta, France, Spain, and Switzerland.

What We Value:

We wholeheartedly embrace agile working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected.

Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO.

Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive.

How to Apply:

If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.

We look forward to hearing from you.

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