Sr Manager, 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 appointment is for a new role is primarily to support Marketing Authorisation Application as well as provide support and expertise on post marketing activities dependent upon the business needs.
Given the nature of the diseases that BioMarin seeks to develop treatments for, this role will provide an individual with the scope to utilize their experience to develop innovative regulatory approaches supported by world class science and exceptional in-house experience in the development and maintenance of products for rare diseases.
Under the supervision of the Director EU, Regulatory Affairs, this role will support development and execution of the EU regulatory strategy of Molecule undergoing a Marketing Authorisation Application review in Europe, with a view to post-marketing activities and development of new indications. The role will support developing European Regulatory strategy, which will require the individual early development as well as late stage and post marketing experience and ideally experience of communicating with and leading HA interactions. The individual will have a positive attitude to regulatory strategy, with good attention to detail and time management as well as have high level of engagement and foster good relationships internal cross functional teams and with regulatory agencies.
The Senior Manager supports the EU lead in the development and execution of EU clinical and non-clinical regulatory strategies through a program’s lifecycle. The EU Snr. Manager supports the execution of EU regulatory activities, including preparation for EMA/NCA interactions and EMA/NCA regulatory submissions (e.g. MAA, CTA) as well as Lead or assist with development of post-approval submissions
Development Stage Product
- Support the development of the EU regulatory strategy and plan.
- Assist with selected planning, document development and meeting execution activities in preparation for EMA meetings / interactions.
- Assist with development of the EU submissions for e.g. PRIME and Orphan Drug Designation, ATMP classification,
- Ensure high quality content that adheres to regulations and guidances.
- Support the maintenance of EU CTAs throughout the life of the studies, may participate in e.g. Study Execution Teams for assigned products for EU specific discussions and considerations
- Partner with global regulatory representatives to confirm CTA requirements as needed
- Ensure transparency and reporting requirements for clinical trials in Europe are understood within BMRN
- Collaborate with Regulatory Project Management to create and align submission timelines,
- Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to EMA
- Oversee the archiving of EMA submissions and correspondence
- Broadly, ensure that the clinical and nonclinical content is adequately presented in EMA/NCA submissions leading to successful product approvals
- With oversight by EU lead, develop and coordinate content for EU regulatory submissions, for example Orphan Drug designation, Module 1 of EU MAA
- During EMA/NCA application review process:
- Collaborate with GRL and SMEs to determine strategy for responses, authoring of responses, and review of responses drafted by SMEs.
- Collaborate with labeling to support nonclinical / clinical Labeling content negotiations with EMA/NCA
- Collaborate on development of EMA/NCA nonclinical / clinical regulatory strategy for post marketing studies with GRL and SMEs that is aligned globally
Commercial Stage Products: in addition to many of the responsibilities outlined above that continue into the commercialized phase, the EU lead at a commercial stage product will have the following responsibilities
- Lead or assist with development of post-approval submissions including variations, MA renewals, annual reports for CMA’s/EC MA’s, PIP modifications, and required submissions such as PBRERS
- Assist with activities related to regulatory compliance and transparency, e.g. EMA Policy 0070, EudraCT postings, sunset clause etc
This position represents a single headcount.
BSc degree (Advanced degree in a scientific field is a plus).
- Knowledge of regulatory frameworks at both EU and Member State level, decision making processes, landscape, touch-points and external environments and the ability to apply these to regulatory solutions throughout the product lifecycle (early phase through clinical)
- Monitoring and evaluating the regulatory environment
- Able to contribute to the development of regulatory strategy
- Able to provide regulatory information and guidance for product development and planning
- Understanding of cross-functional drug development process from phase I – IV
- Understanding of fundamentals of clinical trial design
- Familiarity with relevant fundamental scientific principles, including an ability to understand scientific documentation and regulatory implications
- Ability to understand scientific documentation (i.e. TOPS reports, rudimentary understanding of product manufacture and control) and translate into regulatory submissions development
- Comprehensive understanding of regulatory requirements for drug development
- Comprehensive understanding of laws and regulations for key BioMarin product(s), including the country-specific variations in regulations and guidelines and their impacts
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and proposes solutions
- Comprehensive understanding of the regulatory pathways and market planning, including when and how to file for eg PA/Sci Ad, PIP, PRIME designation, the time points and opportunities for interaction, and the resources required