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RA Specialist II

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 Specialist II is responsible for assisting with the preparation of submissions to

national and international regulatory agencies.  This includes the preparation of drug master files

submissions and amendments, annual reports, and any related correspondence and letters of

authorization.

 

Your Tasks

The role of an RA Specialist II is similar to that of an RA Specialist I but differs in the complexity of tasks assigned.  It is expected that the RA Specialist II will be able to effectively handle complex projects displaying strong project management and good time management skills.

Compile amendments to drug master files for active pharmaceutical ingredients and other substances

Correspond with regulatory agencies and/or customers regarding submissions

Prepare annual reports for regulatory submissions

Maintain records of correspondence with regulatory agencies and customers related to regulatory submissions

Compile and submit site master files to support Bachem GMP operations

Compile technical data packages for active pharmaceutical ingredients and other substances for use by customers in the preparation of their own submissions

Write regulatory affairs guidelines for RA processes

Effectively train new RA employees on RA processes

 

Your Profile

Bachelor’s Degree in Science related field (Chemistry, Biology or equivalent)

Minimum of 3 years’ experience as a Regulatory Affairs Specialist

Experience in cGMP manufacturing, Quality Control, or Quality Assurance

Technical writing experience

Excellent written and oral communication skills

Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Access

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

 

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: Los Angeles