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- Tasks: Lead a global regulatory team and develop innovative strategies for product compliance.
- Company: Essential Pharma specializes in niche medicines, impacting patients in over 70 countries.
- Benefits: Enjoy flexible working, healthcare insurance, generous leave, and a competitive salary starting at £120,000.
- Why this job: Join a dynamic team focused on rare diseases and make a real difference in patient care.
- Qualifications: Extensive experience in global regulatory affairs and leading teams across multiple countries required.
- Other info: Embrace agile working and a culture of trust, autonomy, and personal growth.
The predicted salary is between 72000 - 168000 £ per year.
Essential Pharma is looking for a Senior Director to lead the regulatory team (8) and provide oversight of all global regulatory activities. You will report into the VP for Portfolio Optimization, developing regulatory strategies across all phases of product development and lifecycle management, ensuring compliance with global regulations. Essential have over 300 MAs, a broad portfolio of small molecule established medicines coupled with an emerging biologics portfolio. Apply Today!
What You Will Do
Leading the development and implementation of innovative regulatory strategy, globally, whilst ensuring compliance with local and international regulations.
- Partnering with the business as a strategic partner/advisor to help achieve company objectives including due diligence activities.
- Overseeing and contributing to the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, etc.) to health authorities like the MHRA, FDA, EMA, and others.
- Acting as the primary liaison with regulatory bodies, driving communications, and maximise the likelihood of timely approvals.
- Enhance cross-functional communication with in house and external partners to assure alignment with regulatory strategy.
- Lead and build the regulatory team to develop the knowledge, skills and capabilities to effectively deliver the business strategy. Build a culture of trust and communication so that the team can deliver to the best of their ability.
- Maintain contemporary knowledge of global regulations and ensure effective knowledge sharing across the business.
- Identifying potential regulatory risks and developing mitigation strategies.
What We Do
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. Our products treat patients in more than 70 countries.
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 groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.
In December 2024, Essential Pharma announced a €900 million recapitalisation with partners Gyrus Capital, welcoming AlpInvest and new strategic financing from Sixth Street.
Our business is comprised of around 70 people based out of our offices in Surrey UK, Malta, France, Spain and Switzerland.
What You Will Bring
- Extensive generalist experience in global regulatory affairs within the pharmaceutical, biotech, medical device industry ideally within a dynamic, fast-moving environment.
- Extensive knowledge of preparing and maintaining dossiers for clinical trials and marketing authorizations.
- Experience of seeking advice from and leading meetings with regulatory agencies including the MHRA, EMA. It would be desirable to have a strong knowledge of working with the FDA.
- Experience of leading a growing team and partners across multiple countries and time zones.
- Deep GxP knowledge.
What We Offer
- Salary – from £120,000
- Agile Working – we offer flexibility and trust from day one, it is typical to work 2 days a week at our Egham, Surrey site.
- £150 towards your home office – claim purchases back on expenses.
- Healthcare Insurance
- Pension – you contribute 5% and we offer 3%.
- Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
- Enhanced Family Leave
- Enhanced Sick Pay
- Annual Leave – 26 days plus bank holidays, 3 days shut down between Christmas and NY.
- Annual Performance Bonus
What To Expect
- 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.
- Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.
Senior Director Regulatory Affairs employer: Essential Pharma
Contact Detail:
Essential Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director Regulatory Affairs
✨Tip Number 1
Familiarize yourself with the latest global regulatory guidelines and frameworks, especially those related to the MHRA, FDA, and EMA. This knowledge will not only help you in discussions but also demonstrate your commitment to staying updated in a fast-paced environment.
✨Tip Number 2
Network with professionals in the regulatory affairs field, particularly those who have experience with small molecule and biologics portfolios. Engaging with industry peers can provide insights into best practices and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your leadership style and how you build effective teams. Highlight any past experiences where you successfully led a regulatory team through complex projects or compliance challenges, as this aligns with our focus on team development.
✨Tip Number 4
Be ready to showcase your strategic thinking skills. Think of examples where you developed innovative regulatory strategies that aligned with business objectives, as this is crucial for the role of Senior Director at Essential Pharma.
We think you need these skills to ace Senior Director Regulatory Affairs
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Director Regulatory Affairs position. Tailor your application to highlight your relevant experience in global regulatory affairs and your ability to lead a team.
Highlight Relevant Experience: In your CV and cover letter, emphasize your extensive experience in regulatory affairs within the pharmaceutical or biotech industry. Mention specific examples of your work with regulatory agencies like the MHRA, EMA, and FDA, as well as your experience in preparing regulatory documents.
Showcase Leadership Skills: Since this role involves leading a regulatory team, be sure to showcase your leadership experience. Discuss how you've built teams, fostered communication, and developed skills within your team members in previous roles.
Tailor Your Application: Customize your cover letter to reflect your understanding of Essential Pharma's mission and values. Explain how your background aligns with their focus on niche medicines and your commitment to maintaining compliance with global regulations.
How to prepare for a job interview at Essential Pharma
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive experience in global regulatory affairs. Highlight specific examples of how you've successfully navigated complex regulatory environments and led submissions to agencies like the MHRA, FDA, and EMA.
✨Demonstrate Leadership Skills
Since this role involves leading a team, share your experiences in building and managing teams across different countries and time zones. Discuss how you foster a culture of trust and communication within your team.
✨Align with Company Values
Familiarize yourself with Essential Pharma's values of dynamism, responsibility, trustworthiness, and collaboration. Be ready to explain how your personal values align with theirs and how you can contribute to their inclusive culture.
✨Prepare Thoughtful Questions
Engage with the interviewers by asking insightful questions about the company's regulatory strategies and future goals. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
