Analyst, R&D and Regulatory Policy
Who We Are
From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.
This position is primarily intended to support the Global R&D and Regulatory Policy lead in executing the team priorities. The candidate must be able to effectively track and analyze R&D and regulatory policy issues that could impact BioMarin’s approved products and pipeline candidates, and all involved modalities and disease areas. The individual will report to the Head of Global R&D and Regulatory policy and help coordinate all team functions and processes. Importantly, the individual will support other members of the R&D and Regulatory Policy team and provide project management support related to the functioning of the team itself. Also, the individual will provide executive coordinator support for the Head of the team.
This role entails tracking and analyst support, executive coordinator support, as well as project management support for the R&D and regulatory policy team.
- Monitor, review and inform stakeholders on recently published health authority and regulatory policies and guidance documents impacting development of treatments for rare diseases and advanced therapies in particular.
- Draft and contribute as needed to all types of internal reporting (ad hoc memos, weekly summaries, highlights, digests etc.).
- If required, represent BioMarin on trade association calls and meetings, and generate minutes for the benefit of the regional leads.
- As needed, attend external scientific and regulatory conferences, typically virtually, ensuring key intelligence and highlights are shared with the team and internal stakeholders.
- Support the preparation and follow-up of internal meetings with stakeholders and SMEs, e.g., draft, develop and disseminate agendas, slides, templates, meeting minutes.
- Create, update, and maintain the team’s trackers, engagement maps, internal webpage and SharePoint sites.
- Monitor and document progression of the team objectives and key results (OKRs).
- Provide project management support to the R&D and regulatory policy team, for example in generation of comments on draft guidances.
- Track team memberships and involvement in policy trade associations and organizations.
- Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.
- Lead certain policy cross-functional meetings including minutes and action items.
- Provide strategic logistical support for managing policy calendars and deliverables.
- Develop and manage internal policy publications.
- Develop and manage dashboards for policy team initiatives.
- Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.
- Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.
- Manage Trade Association List and Memberships including main contacts.
- Provide executive coordinator support to the Global Head, R&D and Regulatory policy.
Education & Experience
- Bachelor’s or Master’s degree in biology or other life sciences discipline.
- Project Management Professional would be helpful.
- Thorough understanding of the regulatory environment is a requirement.
- At least 2 years’ work experience in regulatory policy, or project or program management; a minimum of two years’ experience managing teams and team operations desired.
- Pharma/biotech industry experience required, including at least 1 year in Regulatory Affairs and/or policy.
- Outstanding interpersonal and communication (written and verbal) skills is required.
- Strong writing and editing skills for technical documentation.
- Effective task planning and coordination abilities.
- Proficient with computer and standard software programs.
- Experience with MS Office and MS Project Online, or similar scheduling software, required or proven skill at adapting to new software/technology.
- Exposure to electronic document management system(s) (EDMS) and registration tracking systems helpful.
- The candidate should possess the ability to work as part of international and interdisciplinary teams, have strong organizational skills, and understanding of biotech/pharmaceutical industry and nomenclature.
- Strong attention to detail.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.