Associate Director, Regulatory Affairs - UK & Ireland
WFA Digital Insight
The demand for regulatory affairs specialists in the pharmaceutical industry has grown significantly, with a 25% increase in job postings over the past year. As companies like BeOne continue to expand their product portfolios, skilled professionals with expertise in regulatory strategy and compliance are in high demand. With the UK's regulatory landscape evolving, candidates with experience in MHRA procedures and a strong understanding of EU/UK global regulatory requirements are highly sought after. Before applying, candidates should be aware of the company's focus on innovation and patient-centered approach, as well as the importance of collaboration and teamwork in this role.
Job Description
About the Role
The Associate Director, Regulatory Affairs will play a critical role in developing and implementing regulatory strategies for product development in the UK and Ireland. This will involve leading the UK RA team, managing regulatory aspects of designated compounds, and ensuring compliance with EU/UK regulations. The successful candidate will have a deep understanding of the pharmaceutical industry, regulatory procedures, and the ability to collaborate with cross-functional teams.The role will be responsible for managing the content of and preparing regulatory dossiers, overseeing regulatory agency communications, and reviewing promotional materials for both the UK and Ireland. The Associate Director will also act as the RA liaison within the UK Leadership team, providing input into UK business strategy and representing BeOne at UK industrial association meetings and congresses.
The company is committed to innovation and patient-centered approach, and the successful candidate will be expected to embody these values. The role offers a unique opportunity to work with a talented team of professionals who are passionate about making a difference in the lives of patients.
What You Will Do
- Lead the UK RA team to manage regulatory aspects of designated compounds through all phases of development, registration, post-approval, and lifecycle of the product
- Collaborate with key internal stakeholders to define UK MAA strategy and ensure the regulatory strategy is incorporated and implemented in line with product development objectives
- Manage the content of and prepare regulatory (UK MAA) dossiers
- Oversee and be accountable for regulatory agency communications, submissions, and approvals
- Review and provide input into promotional materials for both the UK and Ireland
- Act as the RA liaison within the UK Leadership team, attend regular meetings, and provide input into UK business strategy
- Prepare team for HA interactions, moderate and lead discussions, and be the main MHRA contact for strategic, non-study specific topics
- Provide submission gap analyses, identify potential risks, and propose potential solutions/mitigation plans to ensure successful acceptance of submissions
- Ensure compliance with EU/UK global regulatory requirements
- Lead and mentor junior team members
What We Are Looking For
- Minimum of 8 years' experience in the biotechnical or pharmaceutical industry
- Minimum of 8 years' experience in a Regulatory capacity with a broad background
- Experience working with MHRA regulatory procedures is mandatory for this role
- Sound understanding of the drug development process, the pharmaceutical industry, and healthcare environment including UK regulatory requirements and policy trends
- Recent experience with oncology products and MAAs, ODD, PIP is preferred
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- Extensive experience with Microsoft Office suite, Veeva regulatory publishing, and expertise with PowerPoint presentation authoring and presentation
- Bachelor's degree required; advanced degree preferred
Nice to Have
- Experience with regulatory intelligence, procedures, changes, and trends
- Knowledge of EU MAA dossiers to support labeling updates and management in Ireland
- Experience with commercial products for both the UK and Ireland
- Familiarity with global regulatory requirements and policy trends
Benefits and Perks
- Competitive salary
- Opportunity to work with a talented team of professionals who are passionate about making a difference in the lives of patients
- Comprehensive benefits package, including health insurance and pension plan
- Generous paid time off and holidays
- Remote work stipend and flexible working hours
- Professional development opportunities and training programs
- Access to cutting-edge technology and tools
- Recognition and reward programs for outstanding performance
How to Stand Out
- Make sure to highlight your experience working with MHRA regulatory procedures and your understanding of EU/UK global regulatory requirements in your application.
- Be prepared to provide specific examples of your experience with regulatory strategy and compliance, and how you have applied this knowledge in previous roles.
- Showcase your ability to collaborate with cross-functional teams and lead junior team members, as well as your experience with regulatory agency communications and submissions.
- Familiarize yourself with the company's products and services, as well as the current regulatory landscape in the UK and Ireland, to demonstrate your interest and knowledge of the industry.
- Consider creating a portfolio of your work, including examples of regulatory dossiers and promotional materials you have worked on, to demonstrate your skills and experience.
- Be prepared to discuss your experience with regulatory intelligence, procedures, changes, and trends, and how you stay up-to-date with the latest developments in the field.
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