Senior Manager Regulatory Affairs
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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.
The role will focus on developing and leading the European Regulatory strategy for a new Gene Therapy, which will require the individual to 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 with regulatory agencies. Additional responsibilities will be assigned based on needs of the Regulatory Organisation.
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 Snr. Director EU, Regulatory Affairs, this role will be responsible for developing and executing the EU regulatory strategy for development and submission towards a Marketing Authorisation Application in Europe for a new gene therapy.
Other markets are currently managed from HQ in the US, although the global structure is evolving, and the role may require global input in order to increase the capabilities of the global regulatory function.
The EU Lead conceives, communicates and executes upon EU aspects of the global clinical and nonclinical regulatory strategies throughout a program’s lifecycle, and collaborates with the Global Regulatory Lead (GRL), Global Regulatory Team (GRT) and cross-functionally to ensure that EU needs are appropriately incorporated into the Global Regulatory Plan
- Develop, execute on and maintain the EU aspects of the clinical and non-clinical regulatory strategy of the Global Regulatory Plan (GRP) throughout the product lifecycle, in collaboration with the GRL ensure the needs of the EU for the clinical and non-clinical development plans (and risk/mitigation of any gaps) are appropriately integrated into the GRP
- Collaborate with the GRL to ensure that Health Authority feedback/scientific advice is appropriately incorporated into the global clinical/nonclinical development plans, and that risks/mitigations of not following advice provided by EU HA’s are captured and communicated
- Collaborate with the GRL, and cross-functional SME’s as appropriate, to develop an EU Paediatric Investigation Plan strategy and ensure that the needs of the EU PIP are appropriately reflected in the global paediatric regulatory strategy in the GRP.
- Provide EU strategic input and regulatory expertise to the GRL in the design and conduct of clinical and nonclinical studies based on the interpretation of emerging clinical/non-clinical data from an EU perspective
Health Authority Interactions
- Act as the point of contact for Health Authorities throughout development and lifecycle
- Lead planning and preparation for Health Authority meetings, working closely with SMEs and the GRL to define content that is optimal for the Health Authorities. Deliverables include EU content for the briefing book, EMA/NCA presentation, and the Health Authorities Q&A strategy map.
- Through the GRL ensure that Health Authorities feedback is incorporated into the clinical and nonclinical aspects of the development programs.
- Lead development of the EU submissions for e.g. PRIME and Orphan Drug Designation, ATMP classification, PIPs.
Regulatory Submissions and related activities
- Broadly, ensure that the clinical and nonclinical content is adequately presented in Health Authority submissions leading to successful product approvals.
- Advise global team on core clinical and nonclinical content for EU Health Authority clinical trial applications
- Act as regulatory liaison with study CRO’s to oversee, support and maintain EU clinical trials applications, act as liaison directly with Health Authorities as appropriate (e.g. MHRA).
Marketing Applications (MAs):
- Lead planning and preparation for EU marketing applications, e.g. pre-submission meetings, acts as liaison with Health Authorities staff throughout the filing and review of Health Authorities marketing applications
- Demonstrated ability to contribute to the development of regulatory strategy, able to provide regulatory information and guidance for product development and planning, ability to justify considered strategy and plan.
- Understands key global/ICH regulations that affect program, trial design, pathway options and proactively makes recommendations to optimize regulatory strategy
- Experience in working in a cross functional drug development process, with team members in different time zones.
- Ability to manage critical projects as a part of a multifunctional (matrix) team.
- Demonstrated solid understanding of cross-functional interdependencies across the drug development lifecycle and potential conflicts
- Highly experienced in clinical trials both operational as well understanding of how,
- clinical trial fits into overall product objectives, strategy, required filings, and regulatory commitments.
- Demonstrated understanding of clinical trial protocol objectives, scientific rationale, methodology, and procedures through the life of the clinical trial.
- Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines
- Experience/ understanding of various regulatory pathways and market planning, including when and how to file for e.g. PA/Sci Ad, PIP, PRIME designation, the time points and opportunities for interaction, and the resources required.
- Desirable, demonstrated ability to interact with regulatory agencies and SMEs, including strategies to approach, what to ask, and how to gain needed information, with proven ability to convey highly technical information appropriately for a regulatory agency audience
- Outstanding interpersonal, negotiation and communication (written and verbal) skills
The candidate must interact with project team members from BioMarin as well as partner company (-ies) and with regulatory project managers and other staff from EMA and other national or international health authorities.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.