Roles and Responsibilities Regulatory Affairs Intern

• Supports regulatory activities by assisting with healthcare industry regulatory requirements related to product launches premarket submissions/registrations and postmarket compliance under the guidance of senior regulatory professionals.
• Assists in gathering organizing and reviewing regulatory documentation to support global submissions and compliance activities.
• Develops foundational knowledge of regulatory affairs concepts processes and applicable regulations through hands-on experience and training.
• Applies general academic knowledge gained through education to support team projects and tasks while learning how the Regulatory Affairs team contributes to overall business objectives.
• Performs assigned tasks using established procedures and work instructions; escalates questions or issues to the People Leader or senior team members when guidance is required.
• Collaborates with cross-functional teams (e.g. Quality R&D Operations) to support regulatory projects and resolve routine issues.
• Participates in team meetings and communications asking questions to build understanding and ensure clarity of technical and regulatory information.
• Performs basic data entry and document maintenance including verification and correction of information to ensure accuracy and completeness of regulatory records.

Required Qualifications

• Currently pursuing a Bachelors degree in a related field (e.g. Life Sciences Engineering Pharmacy Biotechnology or a comparable discipline).
• Basic exposure or interest in Quality and/or Regulatory Affairs gained through coursework internships or academic projects.

Desired Characteristics

• Strong oral and written communication skills with the ability to clearly document information and follow instructions.
• Eagerness to learn and develop skills in regulatory affairs and the healthcare industry.
• Basic organizational and planning skills with attention to detail when handling regulatory data and documentation.
• Ability to work collaboratively in a team-oriented environment and take feedback constructively.
• Proficiency with standard office tools (e.g. Microsoft Word Excel PowerPoint) and willingness to learn new systems and processes.