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Regulatory Expert

Your role: We are currently seeking a Regulatory Expert for APIs - based in Altdorf, Switzerland.  You will act as the Regulatory Expert to drive and support regulatory submissions of active pharmaceutical ingredients (APIs) and chromatography materials.  You ensure that relevant changes to product registrations and listings are properly notified to the relevant authorities and maintained.  In-depth knowledge about requirements for filing, registration, and notification of pharmaceutical starting materials, excipients and APIs are desired.

You work in a global regulatory team and drive close interaction with the quality and operational units at the site.  You lead collaboration with internal experts within the Business areas and across the business organization to gather data and support efforts.  You support the manufacturing site to comply with regulatory requirements and good regulatory practices.  You participate as the Regulatory Representative in the product development process to develop and execute regulatory strategies, assessments and plans and may interact with external customers.  

 

 

Your key responsibilities include:

  • Maintain the regulatory activities for APIs and other relevant products (eg., chromatography materials) at the site
  • Lead the preparation and review documents for submission to Regulatory Agencies in compliance with requirements, to ensure their timely written submissions
  • Responsible for technical writing of DMF documents in the dedicated document management system
  • Conduct activities in the e-submission system Eldorado and RIMS (regulatory information management system)
  • Create annual reports for the APIs at the site
  • Lead the issuance of Letters of Authorization (LoA)
  • Support preparation of Product Quality Reports and other regulatory reports based on quality data
  • Perform regulatory assessment of changes per the change control process
  • Prepare and perform Halal Audits for the site on an annual basis,
  • Support local regulations in support of new APIs, and products requiring related regulatory support
  • Drive the creation policies and operating procedures to strengthen regulatory compliance
  • Support the regulatory tracking databases for planning, scheduling, submissions, and action dates, and overall project management
  • Prepare statements and answers to customer requests
  • Lead the provision of responses to customer regulatory queries

 

Who you are:  

  • Bachelor level (or higher) of education in pharmacy or life sciences with a strong emphasis in chemistry or biology
  • Ideally several years (ideally 3 – 5) of relevant industry experience and/or regulatory affairs related to APIs, pharmaceutical excipients and process materials
  • Experience in quality functions such as audit hosting, product quality reviews, and other key quality responsibilities
  • Experience supporting technical customer requests and queries
  • Knowledgeable of US FDA and EU drug regulations, specifically for submissions in CTD format.  Knowledge of regulatory landscape of other important regions, e.g., in Asia.
  • Expertise in QC and QA for pharmaceutical starting materials and requirements of pharmacopeias
  • Experience in submissions in CTD format. Experience in e-submission tools is welcome
  • Knowledge of regulations relevant to pharmaceutical starting materials, quality requirements and preferably processing of APIs and excipients in general.  You should be well-versed in regulatory trends for pharmaceutical raw and starting materials.
  • Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems such as Oracle or SAP. Demonstrate good communication & project management skills. Work successfully within a multidisciplinary international team.

 

Job Requisition ID:  202302
Location:  Uri - all
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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