Bachem Americas, Inc.
1271 Avenida Chelsea, Vista, CA 92081
Regulatory Affairs Project Manager
General Job Description:
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.
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
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
Application Information & Contact (How to Apply)
Please apply through the Bachem Career Website with resume and cover letter
Learn more about Bachem here.