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RA Project Manager

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities

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.

 

Your Tasks

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
 

Your Profile

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

 

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.


Nearest Major Market: San Diego