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Miles
Km80.5

Senior Associate / Manager, Regulatory Affairs

Raptor Pharmaceuticals

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Location: Novato, CA Posted Date: 4/11/2013 Position Type: Full time Job Code: Regulatory Affairs Required Education: Bachelors Degree Areas of Expertise Desired: Regulatory Affairs

Description

The Senior Associate / Manager, Regulatory Affairs is responsible for supporting regulatory activities; will coordinate and prepare documents for submissions; contribute to the completion of projects and ensure compliance with required regulations.  

Responsibilities
. Prepare regulatory documents for submission to the FDA.
. Review technical documentation.
. Liaison with other internal departments regarding documentation and submissions.
. Manage project deliverables and timelines.
. Conduct or participate in meetings with internal teams and government agencies.
. Distribute agendas, take minutes and assign/follow up on action items.
. Maintain regulatory records, including archive of submissions and FDA correspondences files.
. Maintain up to date regulatory knowledge, including regulatory procedures and changes.
. Responsible for making sure submissions comply with applicable regulations and guidance documents.
. Track submissions and ensure timely filing of documents.
. Ensures all assignments are completed within defined timelines and meet regulatory and other company guidelines.
. Other duties as assigned.

Requirements

. 4-year degree in Biological Sciences, Chemistry or Engineering required.
. Experience: 3 / 5+ years of direct experience in Regulatory Affairs.
. Basic / intermediate understanding and utilization of regulations and guidances.
. Experience with pharmaceutical drugs is required; small molecules a plus.
. Ability to work independently.
. Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners.
. Must be flexible when priorities change and have the ability to complete tasks with a sense of urgency.
. Excellent written and verbal communication skills.
. Must be able to work successfully within a team.

Raptor Pharmaceuticals - 9 Commercial Blvd, Suite 200, Novato, CA 94949
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