Job Description Summary
Supports regulatory strategy activities by assisting the business in understanding healthcare industry regulatory requirements related to product launch, premarket submissions/registrations, and postmarket compliance. Works under supervision and collaborates with experienced team members, including interactions with healthcare regulatory bodies as appropriate. Develops foundational knowledge of regulatory affairs principles and the professional discipline. Provides support on projects that may require basic technical knowledge or exposure to specialized regulatory topics across a broad area.
Job Description
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 Bachelor’s 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.
Additional Information
Relocation Assistance Provided: No