\\nMISSION:

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we\\xe2\\x80\\x99re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. We are collaborative, creative, and experienced professionals and we\\xe2\\x80\\x99re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it\\xe2\\x80\\x99s like to be a part of our team: www.mirumpharma.com.

Job Summary:

As an Intern in Regulatory Affairs International team, you will work closely with the regulatory affairs team to ensure compliance with applicable regulations, standards, and guidelines governing the development, manufacturing, and marketing of pharmaceutical products. This entry-level position provides an excellent opportunity to gain practical experience and knowledge in the field of regulatory affairs while contributing to the overall success of the organization.

***This will be a 6 month assignment, 40 hours/week, paid internship****

Responsibilities and main tasks:

• Support the preparation of regulatory documents to ensure compliance with local, regional, and international regulations.
• Liaise with RA CMC, RA Labelling, Regulatory Operations & other supportive functions to collect all the information required for preparation of regulatory activities.
• Ensure timely execution of regulatory activities as per the plan set up with the line manager.
• Support the RA International team to maintain tracking tools and regulatory databases up to date.
• Organize and maintain regulatory files and databases, ensuring accuracy, completeness, and confidentiality of information.
• Assist in the preparation and maintenance of working instructions, and other relevant documents related to regulatory affairs.
• Conduct research on regulatory requirements and stay updated with changes in regulations and guidelines.
• Provide appropriate support to the RA team.
• Attends and actively participate to RA department meetings.

Minimum requirements:

• Bachelor\\\'s degree in a scientific discipline.
• Good command in English (written and spoken), any other language- advantage.
• Basic understanding of pharmaceutical regulations (e.g. FDA, EMA) is an advantage.

Required skills:

• Excellent organizational skills with keen attention to detail.
• Excellent communication and interpersonal skills
• Proficient in using computer applications and databases.
• Ability to work effectively both independently and within a team.
• Demonstrated ability to prioritize tasks and meet deadlines.

Benefits for you:

• Gain meaningful professional experience in the field of Regulatory Affairs
• Gain cross-functional insight learning how to work in a global company
• Working in a friendly and international environment with a collaborative spirit
• Given an opportunity to improve personal growth and development

Application need to include a CV and a motivation letter answering these questions:

• Why do you want to do an internship in Regulatory Affairs?
• What relevant skills and experience can you bring to this position?

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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran\\xe2\\x80\\x99s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

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