Director, Regulatory PolicyLocation 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.
The Director Regulatory Policy will be responsible for ensuring that the Regulatory team within the European organisation are kept abreast and informed on EU policy issues and changes made by the EMA and other member states, with a particular focus on policies relating to rare disease, gene therapies and paediatrics. (S)he will represent BioMarin on external Trade Associations and Committees, playing a key role in helping to shape regulatory policy in areas relevant to BioMarin’s business. This is a European role, working closely with Regulatory Policy counterparts in the US and Asia, and reporting to the US-based Executive Director.
- Responsible for European regulatory policy initiatives and activities. This key role is responsible for assessing, integrating, shaping, maintaining and advocating BioMarin’s regulatory policy position.
- Work collaboratively to build and maintain relationships with key regulatory authorities and industry associations; assess the current regulatory environment; anticipate regulatory trends; and develop/maintain a deep understanding of guidance’s, regulations and laws that impact BioMarin’s product portfolio and business objectives.
- Work closely with internal stakeholders to understand their challenges and position with regards to regulatory policies.
- Act as the lead and subject matter expert for all Regulatory Policy matters across the European region.
- Advise senior management of European regulatory requirements and standards related to product development, with a focus on policies relating to rare disease, gene therapies and paediatrics.
- Develop and maintain strong relationships with European Regulatory authorities.
- Collaborate and lead internal development of BioMarin’s responses to the EMA and other government agencies, standards development organisations, etc. on regulations, guidance, legislative initiatives and standard topics of interest to BioMarin.
- Represent BioMarin within industry associations on regulatory policy matters. Participate in, secure and hold key leadership positions in industry working groups to foster relationships and build advocacy strategies that enhance BioMarin’s objectives and those of the patients they serve.
- Proactively monitor emerging regulatory policy and scientific trends/issues/topics related to rare disease, gene therapies and paediatrics – this includes topics with the EMA and other European regulators, industry consortia, other regulatory/governmental agencies. Identify, assess and communicate those topics likely to impact BioMarin’s product portfolio.
- Perform time-sensitive analysis, draft revisions and amendments to relevant regulations, standards, and legislative documents.
- Prepare briefing materials, presentations, research and other materials for executive management, colleagues, and industry meetings.
- Attend and present at various internal meetings – seeking input from key stakeholders and ensuring BioMarin staff within the European organisation are fully briefed on all relevant aspects of regulatory policy.
The role requires an experienced regulatory professional; someone who understands the regulatory landscape and who can think strategically, as well as tactically about the emerging regulatory policies and the impact they have on the business. Key requirements include:
- Educated to a minimum of first-degree level.
- Excellent communication skills. Ability to establish network and working relationships both internally and externally.
- Excellent collaboration skills and ability to work in a team environment and individually.
- Experience and track record of effective collaboration within industry associations groups and/or with regulatory authorities via international forums.
- Ability to manage/lead internal and external topic focus groups, task forces, committees and working groups.
- Proven ability to react quickly to topics facing the industry in which BioMarin operates. Demonstration of strategic and proactive thinking as well as ability to manage numerous topics concurrently. Strength in prioritising and anticipating emerging issues.
- Knowledge of current European Health Authority requirements and industry standards, particularly in the field of rare diseases, gene therapies and paediatrics would be ideal.
- Experience acting as a credible, reliable, influential and respected spokesperson on behalf of BioMarin and/or industry association groups during interactions with regulatory authorities to ensure appropriate, proactive communication with agency officials on key topics.
- Superior organisational, presentation, oral and technical writing skills. Proven ability to effectively and persuasively communicate complex topics at the highest levels of business and government.
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.