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Regulatory Expert API, Arklow

Your role:


An exciting opportunity has arisen for a Regulatory Expert for APIs based in Arklow, Ireland.

The Regulatory Expert will support regulatory submissions of active pharmaceutical ingredients (APIs) and excipients.  This role will 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 is required.  In addition, knowledge of import and export requirements related to Good Distribution Practices for APIs is also a plus.  

This role will be part of a global regulatory team and you will interact closely with the quality and operational units at the site.  You will collaborate with internal experts within the business areas and across the business organisation to gather data and support efforts.  Participation as the Regulatory Representative in the product development process to develop and execute regulatory strategies, assessments and plans is key, and interaction with external customers will be required.  


Key responsibilities include:


  • Technical writing of DMF documents in the dedicated document management system
  • Support regulatory requirements on import and export of APIs
  • Prepare and review documents for submission to Regulatory Agencies in compliance with requirements, to ensure their timely written submissions
  • Support the regulatory tracking databases for planning, scheduling, submissions, and action dates, and overall project management
  • Create policies and operating procedures to strengthen regulatory compliance
  • Support the issuance of Letters of Authorization (LoA)
  • Support provision of responses to Customer Regulatory Queries
  • Drive and Support provision of responses to Customer Regulatory issues


Who you are:  

  • Bachelor or Master level of education in Pharmacy or Life Sciences with a strong emphasis in Chemistry or Biology
  • Relevant industry experience and/or regulatory affairs related to APIs, pharmaceutical excipients and process materials
  • 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:  203139
Location:  Arklow
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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