Essential Pharma is looking for a Global Head of Regulatory Affairs to lead the regulatory team and provide oversight of all global regulatory activities. You will lead and develop regulatory strategies across all phases of product development and lifecycle management, ensuring compliance with global regulations.
What You Will Do
1. Leading the development and implementation of innovative regulatory strategy, globally, whilst ensuring compliance with local and international regulations.
2. Partnering with the business as a strategic partner/advisor to help achieve company objectives including due diligence activities.
3. 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.
4. Acting as the primary liaison with regulatory bodies, driving communications, and maximizing the likelihood of timely approvals.
5. Enhancing cross-functional communication with in-house and external partners to assure alignment with regulatory strategy.
6. Leading and building the regulatory team to develop the knowledge, skills, and capabilities to effectively deliver the business strategy.
7. Building a culture of trust and communication so that the team can deliver to the best of their ability.
8. Maintaining contemporary knowledge of global regulations and ensuring effective knowledge sharing across the business.
9. Identifying potential regulatory risks and developing mitigation strategies.
What You Will Bring
1. Extensive experience in global regulatory affairs within the pharmaceutical, biotech, medical device industry ideally within a dynamic, fast-moving environment.
2. Extensive knowledge of preparing and maintaining dossiers for clinical trials and marketing authorizations.
3. Experience of seeking advice from and leading meetings with regulatory agencies including the FDA, EMA, and others.
4. Experience of leading a growing team and partners across multiple countries and time zones.
5. Deep GxP knowledge.
What We Offer
1. Salary – from £120,000
2. Agile Working – we offer flexibility and trust from day one, it is typical to work 2 days a week at our Egham site.
3. £150 towards your home office – claim purchases back on expenses.
4. Healthcare Insurance
5. Pension – you contribute 5% and we offer 3%.
6. Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
7. Enhanced Family Leave
8. Enhanced Sick Pay
9. Annual Leave – 26 days plus bank holidays, 3 days shut down between Christmas and NY.
10. Discretionary Annual Performance Bonus
11. Recognition Program – from shout outs, vouchers and up to £2000 for gold awards!
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.
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.
#J-18808-Ljbffr