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Manager (Clinical), Regulatory Affairs

BioMarin Pharmaceutical Inc.

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Location: San Rafael, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 13-0041 Required Education: High school or equivalent

Description

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 four 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.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 13-0041

The purpose of this position is to manage the clin-nonclin liaison aspects of global regulatory affairs activities in support of product development. Both early and late-stage development projects as well as marketed products will be supported. The position will also support our Corporate partners with their international regulatory filings.

RESPONSIBILITIES:
• Oversee BLA, NDA,IND, CTA maintenance and the submission of amendments
• Support planning, preparation, and submission of INDs and BLAs and NDAs
• Provide strategic insight to the project team regarding product development plans
• Manage interactions with FDA or other regulatory authorities
• Interviewing, selecting and training employees.
• Managing direct reports
• Customarily and regularly exercise discretion and independent judgment in the performance of the duties described above.


To apply: Visit www.BMRN.com Job Code 13-0041

Requirements

EDUCATION:

BS degree in life sciences (Advanced degree is desirable).

EXPERIENCE:
• The candidate is expected to have at least four years of experience in clin-nonclin aspects of Regulatory Affairs in the biotechnology or pharmaceutical industries, preferably with exposure to both development and commercial phases of the product lifecycle.
• The candidate should have proven ability to manage critical projects as part of an interdisciplinary team.
• The candidate should have experience managing major regulatory submissions, with the ability to successfully manage projects to deadlines.
• The candidate is expected to have a thorough understanding of relevant drug development regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
• The candidate should have experience interacting with regulatory health authorities (e.g., FDA, EMA).

To apply: Visit www.BMRN.com Job Code 13-0041
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