Project Manager, Regulatory Affairs - Vista, CA | Biospace
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Project Manager, Regulatory Affairs

Bachem

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Location:
Vista, CA
Posted Date:
8/9/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Pharmaceutical, Project Manager, Regulatory Affairs,

Job Description

JOB SUMMARY

The Regulatory Affairs Project Manager is responsible for managing all regulatory submissions to national and international regulatory agencies both electronically and in paper form. This includes the preparation, submission, and periodic update of drug master files and any related correspondence and Letters of Authorization/Access. This individual will also be responsible for the maintenance of regulatory dossiers, internal and external customer support, and review of GMP documents for compliance with regulatory guidelines.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

•   Compile and submit drug master file for active pharmaceutical ingredients and other         substances (i.e. U.S., Canada, Europe, Asia, Mexico, and South America)
•   Correspond with regulatory agencies and customers regarding submissions
•   Compile and submit responses to questions regulatory agencies have regarding submissions
•   Maintain schedule and complete annual reports for all regulatory submissions
•   Maintain records of all regulatory submissions and associated Letters of Authorization/ Letters of Access
•   Maintain records of all correspondence with regulatory agencies and customers
•   Compile and submit Site Master Files to support GMP operations
•   Compile technical data packages for active pharmaceutical and other substances for use by customers in the preparation of their own submissions

Requirements

MINIMUM QUALIFICATIONS

Required:

•   BS degree in Science discipline - Chemistry, Biochemistry or equivalent
•   At least 5-8 years of relevant experience
•   Experience corresponding and interacting with regulatory agencies, particularly with the FDA.
•   Experience with preparation of Chemistry, Manufacturing, and Controls sections for regulatory submissions
•   Experience with cGMP manufacturing, Quality Control, or Quality Assurance
•   Technical Writing Skills
•   Exposure to e-CTD Software programs
•   Excellent written and oral communication skills
•   Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
•   Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
•   Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
•   Detail oriented with the ability to troubleshoot and resolve problems
•   Ability to work independently and manage one’s time
•   Communicate effectively and ability to function well in a team environment

Preferred:

•   Experience working with regulatory agencies