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Regulatory Affairs Specialist I

Company Name: Bachem
Location: Torrance
Job Type: Full Time
Contact Name: Danielle Bell-Ellison
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Fax:
Email:
Salary:

Job Description

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.

Bachem. Pioneering Partner for Peptides

Your Responsibilities:

The Regulatory Affairs Specialist I 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:

• Assist with compilation of drug master files for active pharmaceutical ingredients and other substances
• Prepare annual reports for regulatory submissions
• Maintain records of regulatory submissions and associated letters of authorization
• Maintain records of correspondence with regulatory agencies and customers related to regulatory submissions
• Assist with DMF amendments
• Assist with technical data packages for active pharmaceutical ingredients and other substances for use by customers in the preparation of their own submissions

Your Profile:

• Bachelor`s Degree in Science related field (Chemistry, Biology orequivalent)
• 1-2 years of experience in cGMP manufacturing, Regulatory Affairs, 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.

Interested?

Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) online to Danielle Bell-Ellison. 1271 Avenida Chelsea, Vista, CA 92081, Tel.: +1 310 784 4440

Application-Link:https://workforcenow.adp.com/jobs/apply/posting.html?client=bachem&jobId=192537&lang=en_US&source=CC3