Sr. Associate, Regulatory Affairs

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

BioMarin is pleased to offer a comprehensive benefits program that extends beyond that commonly seen in the biotech industry. Currently, there are no out of pocket costs for eligible employees and their eligible dependents.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job# 08-0071

SUMMARY DESCRIPTION
This position is responsible for the coordination, preparation and submission of a variety of regulatory submissions for a small molecule drug product candidate in several therapeutic indications.

RESPONSIBILITIES
• Coordinate the preparation and submission of domestic and international regulatory submissions, including the following:
o INDs or international equivalents and amendments
o NDAs, BLAs, ANDAs or international equivalents and amendments
o Orphan drug applications
o Information related to clinical trials including protocols, investigator brochures and investigator information
o Annual Reports

• Assist in coordination of meetings with Reg Authorities and associated briefing document preparation.
• Attend relevant functional area and project team meetings, including Nonclinical and Clinical/Regulatory subteams
• Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary
• Other duties as assigned.

EDUCATION
• Four year degree in Biology, Chemistry, or other Life Science

EXPERIENCE
• Minimum 2 years experience in Regulatory or equivalent training and experience in related function such as Clinical or Nonclinical; preferred 2 years experience in Regulatory
• Proficiency with computer and standard software programs is required
• Excellent verbal and written communication skills
• Attention to detail

To apply: Visit www.BMRN.com Job# 08-0071