Sr Director, Regulatory AffairsLocation London, United Kingdom Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
This role is to lead the team responsible for the management of a portfolio of products and partner with the relevant functions regionally (EU/EEA, UK and CH) and in US based headquarters to oversee the regulatory aspects of BioMarin’s business at a regional and country level. This role will focus on team leadership, cross-functional partnership, and oversight of all EU related regulatory activities primarily for the assigned marketed products. The successful candidate will lead a high performing team, maintain a collaborative team culture in line with BioMarin core values, and oversee relevant EU Regulatory Affairs activities to ensure alignment with BioMarin corporate and regional goals. The role reports into the Vice President, EU Regulatory Affairs.
Regulatory Affairs EU strategy and execution
- Primary responsibilities include overseeing the planning and execution of regional launch and commercialization activities and support for commercial/marketing, market access, PV, healthcare compliance and quality/supply chain throughout the product lifecycle and across the region.
- Oversee the filing and review of EMA/NCA applications for the marketed products eg lifecycle submissions for CAP licences, national licences for UK and CH (through partner)
- Oversee maintenance of of EMA/NCA approved product licences, including regulatory activities related to post-marketing studies, variations, PAMs, PBRERS etc
- Partner closely with other regulatory disciplines involved in EU development and post-approval regulatory affairs activities and deliverables, including Regulatory CMC, Regulatory Labelling, Regulatory Operations
- Oversee planning, preparation, submission and maintenance of CTA’s in EU countries by staff, and liaison role with CRO’s
- Oversee the EMA/NCA Health Authority interactions for products in the portfolio
- Oversee regulatory compliance activities for products in the portfolio, e.g. clinical trials reporting and transparency requirements.
- Manage and resolve escalated issues; mitigate product risks and identify opportunities affecting EU activities for managed portfolio
- Ensure EU processes and procedures are carried out in a compliant and consistent manner
Team Leadership and Management
- Manage a cohesive, balanced and high functioning team of EU regulatory staff focused on producing high quality regulatory deliverables and outcomes
- Optimize allocation of team resources across portfolio of products and manage allocated budget
- Lead recruiting, hiring, promotions and team management efforts, in collaboration with HR, for managed EU staff
- Mentor and guide managed EU staff on BioMarin career development
- Identify and advocate for training and tools in support of EU regulatory staff skill development
- Cross-functional leadership
- Advocate, collaborate, facilitate and drive synergy and best practice sharing across Global Regulatory Affairs functions
- Collaborate with regional stakeholder functional areas (e.g., Development Sciences, Medical Affairs, Commercial, Market Access, PV, Healthcare Compliance) to build alignment, collaboration, and information sharing
- Lead, or participate in, key Regulatory Affairs strategic, change or improvement initiatives
- Clearly define roles/responsibilities for product activities and deliverables across the regulatory disciplines and cross-functional stakeholder functions
Decision Making and Problem Solving, including an ability to coach and mentor teams to develop creative and novel solutions
Influence, Cross-Functional Collaboration and Organizational Awareness, including an ability to leverage organizational knowledge, tact, and connections to stakeholders across the organization to extract necessary information quickly and effectively while strengthening inter-departmental relationships
Agility and Proactivity, such as consistently expecting, driving for and delivering excellence and optimal outcomes.
Leadership, such as skill in building high functioning, effective teams that receive positive feedback from stakeholders
Communication, including an ability to ensure that employees, at all levels, fully understand their roles in achieving success
Strategic Thinking and Planning, such as an ability to hold in mind the vision and purpose of the function, along with broader company objectives, when making decisions
Regulatory Strategy and Frameworks: such as an ability to effectively develop and represent the regulatory position/solution in challenges associated with lifecycle/commercialization.
Scientific Writing for Regulatory Submissions: Able to conduct comprehensive regulatory submission document evaluations including evaluation of the quality and completeness of content
EDUCATION AND EXPERIENCE
Degree in health or life sciences, significant experience in European regulatory affairs including the post-approval management of centralised product licences, and of the regulatory aspects associated with managing CAP licences at a country level. Knowledge of regulatory frameworks at both EU and Member State level, and the ability to apply these to regulatory solutions. Experience in management/leadership, development and retention of high quality regulatory affairs professionals.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.