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Director of Regulatory Affairs

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.

Your Responsibilities

 

The Director or Regulatory Affairs manages the RA employees and oversees the day-to-day operations of the Regulatory Affairs department at both Bachem US sites (Vista & Torrance). The Director of Regulatory Affairs is responsible for the regulatory filing strategy for US FDA and other regulatory agencies. This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to Drug Mater File submissions, Annual Reports, as well as responses to requests from these agencies. The incumbent oversees and participates in the preparation of submissions of drug master file (DMF) for API to US/Global health authorities. The RA Director will also provide technical data packages to customers for preparation of their own submissions.

 

Your Tasks

·         Hire, manage, and develop teams to support Regulatory Affairs activities at two locations

·         Manage continued growth, development, and retention of the team

·         Directly manage a team of regulatory affairs project managers and specialists at Bachem Americas

·         Establish Priorities and set goals for the Regulatory Affairs function

·         Ensures the regulatory affairs department is properly trained as well as coach and mentor direct reports

·         Develop strategies for DMF filing with FDA and other regulatory agencies

·         Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs

·         Provide regulatory leadership and guidance to project teams

·         Oversee multiple projects involving drug master files submissions, amendments, annual reports, and any related   

          correspondence and letters of authorization for two locations

·         Compile and submit drug master files for active pharmaceutical ingredients

·         Develop response strategies and submissions to regulators’ requests

·         Contact regulatory agencies relevant to assigned projects or programs, as appropriate

·         Prepare annual reports for regulatory submissions

·         Develop and maintain a schedule of periodic updates for all regulatory submissions. Ensure   updates are filed within   

          timelines

·         Maintain records of regulatory submissions, associated letters of authorization and technical data packages

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

·         Compile 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 a Science related field - Chemistry, Biology or equivalent

·         Solid Chemistry background

·         Minimum of 8 years of experience in a regulatory affairs function including regulatory submissions, corresponding and

          interacting with regulatory agencies, particularly FDA

·         At least 5 years of experience in people management and leadership

·         Experience with the preparation of Chemistry, Manufacturing and Control sections for regulatory submissions

·         Experience with compiling and submitting drug master file for bulk drug substance

·         Ability to interact well with customers, co-workers and regulatory authorities

·         Ability to function well in a team environment

·         Strong organizational skills

·         Excellent written and oral communication skills

·         Proficient 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

·         Ability to work independently and manage one’s time

 

        Preferred:

·         Master’s Degree in a Science related field or Regulatory Affairs

·         Regulatory affairs Certification through the Regulatory Affairs Professional Society

·         Technical writing experience

 

 

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

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