Intern – 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. 

SUMMARY:

The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry.

BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.

BioMarin Regulatory Patient Engagement & Outcomes Research (PEOR) team develops and executes the US and EU patient engagement strategy and global patient-centered outcomes research strategy for relevant programs. The PEOR team ensures that patient input impacts the development and implementation of regulatory internal processes and with an eye toward translating this into support of positive external (regulatory health authorities) evaluation of BioMarin submissions. The team has an important responsibility to lead and support incorporation of the patient voice and collective patient experience data (PED) in the regulatory process. The team also provides subject matter expertise to support the selection, incorporation, and evaluation of Clinical Outcome Assessments (COAs) for use across programs and ensures early development and implementation of robust plans to ensure COAs satisfy regulatory standards and support product approval.

JOB DESCRIPTION/PROJECT:

The Intern position would be working across both the Clinical/Nonclinical Regulatory Affairs team and the Regulatory Engagement & Outcomes Research team. Responsibilities may include:

• synthesizing/collating cross-functional Stakeholder insights to better characterize and coordinate messaging on unmet need in targeted patient populations to gain skills in information synthesis and regulatory strategic planning.
• gathering information on strategic approaches for addressing measurement gaps in pediatric and adult studies to learn about regulatory strategy, endpoint development, and measurement considerations.
• lead formalization of the regulatory annual reporting process from the clinical regulatory and regulatory project management perspective.
• lead a periodic-report Standard Operating Procedure alignment review and discussion and develop an inspection-readiness document template.
• develop templates for management of contract research organizations through reviewing, synthesizing, and collating existing documentation, gaining exposure to the inspection side of regulatory, as well as some of the other commercial and development team obligations.

Required Skills:

• Knowledge of basic health sciences (biology, epidemiology, Public Health, Psychology, Health Research)
• Advanced knowledge of Microsoft Office Suite
• Basic understanding of drug development pipeline
• Strong written communication and information synthesis skills

Desired Skills:

• Intermediate/advanced background in biology or related healthsciences
• Qualitative and/or quantitative science background
• Enthusiasm to learn and tackle new projects

Qualifications/Eligibility:

• Undergraduate student in their senior year in pursuit of obtaining a Bachelor’s degree or Graduate student in pursuit of a Master’s Degree in biology or related science field (health sciences, epidemiology, Public Health, Psychology, Health Research).
• Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program.
• Must be available to work full-time, 40 hours a week.
• Must be authorized to work in the United States without VISA sponsorship.
• Able to work remotely within United States borders.

Benefits of a BioMarin Internship:

• Fully remote/virtual experience; company owned laptop provided for the duration of the internship program.

• Gain hands-on experience in the daily operation of a commercial biotech company.
• Apply skills and knowledge learned in the classroom to on-the-job experiences
• Comprehensive, value-added project(s).
• Work in teams and with colleagues in a professional environment.
• Develop skills specific to your major.
• Opportunities for professional development by building relationships and learning about other parts of the business.
• Weekly Speaker Seminar Series with Executive Staff.

At BioMarin, we are about making a big impact on rare patient populations, and this takes the widest possible range of ideas. To find solutions for the patients we serve, our workforce must represent diversity in all its forms.

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.