Industrial Pharmacy Residency Program


The specialized Industrial Pharmacy Residency Program in Global Product Development Regulatory Affairs is targeted toward recent graduates of pharmacy programs and is designed to be exploratory, project-based and self-directed. The Resident will focus on Global Product Development Regulatory Affairs to develop in-depth knowledge and experience in this discipline. 

Objectives
Upon completion of the program, the Resident will have sufficient knowledge and experience in Global Product Development Regulatory Affairs to enable the individual to pursue future career entry opportunities in the pharmaceutical industry. Key objectives of the program include:

  • Understand the importance of the role of the global pharmaceutical industry in the provision and improvement of health care.
  • Understand the role of the Global Product Development Regulatory Affairs Department within the company.
  • Recognize the variety of opportunities available to pharmacists and promote the value of a clinically-trained pharmacist within the pharmaceutical industry
  • Develop highly marketable skills for employment opportunities within the pharmaceutical industry.

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Global Product Development


Overview
Successful drug development within the pharmaceutical industry requires compliance with global regulations and collaboration with global health authorities. Regulatory professionals provide the interpretation of global regulations within their companies to facilitate drug development that meets the needs of Health Authorities, patients, and prescribers. Regulatory professionals are responsible for the design and implementation of regulatory strategies to optimally develop, license, and market products globally.

At Roche, Regulatory Affairs Residents will receive individual guidance from regulatory professionals and obtain an understanding of the regulatory roles and responsibilities in the drug development process. Each Resident will learn how to apply regulations and health authority guidelines in the drug development process, develop regulatory strategies in collaboration with global project teams, and interact with Health Authorities.

Fulfillment of the objectives will be facilitated through the completion of multiple projects and activities within our Product Development Regulatory Affairs department. The following areas will allow the Resident to have cross-functional exposure within the department. 
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Documentation

  • Scheduling, writing, editing, publishing and distribution of Medical (Clinical and Safety) documentation for submission to global regulatory agencies

  • Participation in the resourcing/outsourcing activities of clinical and safety documents in accordance with approved vendors

  • Actively support the project management of report deliverables, assisting in tracking and overseeing key milestones

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​​​​​​​Program Management

  • Participate in the development and implementation of global and local innovative regulatory strategies for the development of Roche Products

  • Providing guidance on regulatory procedures and requirements

  • Research and support development of regulatory strategic options and assessments of risk for business-critical decisions

  • Participate in new filings (e.g. new indications, new formulations) based on business needs and/or global Health Authority requirements as appropriate
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Operations

  • Provides coordination, compilation, publishing, and submission expertise in the preparation of new and existing regulatory applications.

  • Working closely with Regulatory and cross-functional colleagues, the team supports the preparation of high-quality dossiers that meet the requirements of health authorities worldwide.
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  • Provides effective and efficient management of regulatory information and standards through planning, tracking, submission, and archiving of the information within our systems
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Labeling

  • Participate in the development and update of Core Data Sheets (CDS), US Prescribing Information (USPI) and EU Prescribing Information (PI) with Regulatory Program Management and cross-functional experts

  • Participate in the assessment and development of general and issue-related label strategies

  • Provide regulatory labeling guidance and advise Life Cycle Team (LCT)/Established Products Team (EPT) and internal working groups on CDS, USPI and EU PI content
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  • Ensure changes and safety signals from CDS updates are implemented into local product labels

Residency components


Mentorship Program
​​​​​​​The duration of the program is 104 weeks (2 years)
The mentorship program pairs Residents with experienced mentors currently on their team. This provides the Residents with additional support in their day-to-day activities outside of their co-residents and managers. The mentorship program aims to give Residents continued career guidance and professional development.
Roche Residency Alumni Careers
  • Senior Documentation Scientist, Product Development Regulatory, Roche
  • Program Manager, Program Management, Product Development Regulatory, Roche
  • Associate Director, Program Management, Product Development Regulatory, Roche
  • Labeling Program Manager, Product Development Regulatory, Roche
  • Senior Associate Labeling Manager, Product Development Regulatory, Roche
  • Program Manager, Program Management, Global Product Technical Regulatory, Roche 
  • Clinical Project Manager, Product Development Regulatory, Roche
  • Lead Clinical Scientist, Product Development Neuroscience, Roche
  • Associate Regulatory Submissions Manager, Product Development Regulatory, Roche
  • Quality Solutions Leader, Product Development Quality, Roche
  • Patient Experience - Patient Support Programs, Roche
  • Evidence Generation & Strategic Collaborations, Roche
  • Engagement Manager, Clearview Healthcare Partners
  • Medical Science Liaison, Takeda
  • Medical Science Liaison, Boehringer Ingelheim
  • Medical Science Liaison, Lundbeck
  • Medical Science Liaison, Ferring
  • Field Medical Advisor, Pfizer
  • Medical Director, Sanofi
  • Scientific Evaluator, Health Canada

Administrative Info


The Hoffmann-La Roche Industrial Pharmacy Residency Program – Specialty in Global Product Development Regulatory is coordinated jointly with the Faculty of Pharmacy, University of Toronto. The Resident receives insight and direction from the Faculty of Pharmacy Liaison and the Roche Residency Program Director. Together, these individuals cooperate to maximize the Resident’s experiences at Hoffmann-La Roche Limited.  This program is not suited for individuals with advanced academic degrees and research experience or with extensive related work experience. 

Interested candidates should apply through the Leslie Dan Faculty of Pharmacy, University of Toronto Industrial Pharmacy Residency Program (IPRP) Application. These applications are accepted in the fall of every year (September-October). Further information about IPRP can be found below:

Apply to UTO residency program here