Intern, Regulatory Affairs
Description
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
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.
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
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.
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. Over the course of 10 - 12 weeks our interns gain industry experience while working alongside our talented team on meaningful projects.
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 global 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 global 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.
JOB DESCRIPTION/PROJECT:
The Intern position would be working within the Clinical/Nonclinical Regulatory Affairs team. Responsibilities may include:
- Categorize and document health authority questions within department document management system
- Support regulatory team with aspects of new IND filing(s) and/or health authority meeting preparations
Required Skills:
- Advanced knowledge of Microsoft Office Suite (Word, PowerPoint, Excel)
- Strong written communication and information synthesis skills
- Knowledge of basic health sciences
- Basic understanding of drug development pipeline
Desired Skills:
- Enthusiasm to learn and tackle new projects
- Qualitative and/or quantitative science background
- Intermediate/advanced background in biology or related health sciences
Qualifications/Eligibility:
- Bachelor's or Master’s Candidate in biology or related science field (Health Sciences, Epidemiology, Public Health, Health Research, etc.)
- Must be available to work full time, 40 hours a week.
- Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program.
- Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles. Some positions will be open to remote interns, but employee must be within United States borders.
Benefits of a BioMarin Internship:
- Paid hourly wage, paid company holidays, and sick time
- Apply skills and knowledge learned in the classroom to on-the-job experiences
- Comprehensive, value-added project(s)
- Develop skills specific to your major.
- Opportunities for professional development by building relationships and learning about other parts of the business.
- Participate in company all hands meetings, monthly community lunches
- Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
- Access to Employee Resource Groups
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
In the U.S., the salary range for this position is $21 to $30 per hour, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.