Regulatory Affairs Project Manager

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Job description

Your Responsibilities

The Regulatory Affairs Project Manager is responsible for managing regulatory submissions to national and international regulatory. 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. The Regulatory Affairs Project Manager will serve as project team member representing RA in both internal and customer meetings.

Your Tasks

• Compile and submit drug master files for active pharmaceutical ingredients and other substances globally (i.e. U.S., Canada, Europe, Asia, Mexico, and South America) with little to no supervision
• Correspond with regulatory agencies and customers regarding submissions
• Compile and submit responses to questions that regulatory agencies have regarding submissions

• Maintain schedule and complete annual reports for regulatory submissions
• Maintain records of regulatory submissions and associated Letters of Authorization/ Letters of Access
• Maintain records of all correspondence with regulatory agencies and customers
• Compile technical data packages for active pharmaceutical and other substances for use by customers in the preparation of their own submissions
• Serve as project team member representing RA in both internal and customer meetings
• Influence others to complete tasks in support of regulatory submissions
• Identify and lead process improvement initiatives
• Assess change controls for regulatory impact

Your Profile

• BS degree in Science discipline - Chemistry, Biochemistry or equivalent (strong chemistry background)
• At least 5-8 years of relevant experience
• Experience with preparation of Chemistry, Manufacturing, and Controls sections for regulatory submissions
• Experience with cGMP manufacturing, Quality Control, or Quality Assurance
• Strong technical writing skills
• Excellent written and oral communication skills
• 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
• Ability to independently lead cross functional meetings to address questions from health authorities or customers
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one's time
• Ability to communicate effectively and function well in a team environment
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint

Preferred:

• Experience corresponding and interacting with regulatory agencies
• Experience with peptide chemistry
• Exposure to eCTD Software programs

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you

are looking for a new challenge and want to join a motivated team in an internationally renowned

company, you should seize this opportunity.