Intern - Regulatory Affairs

1 month ago

Foster City, United States Mirum Pharmaceuticals Inc Full time

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're 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 diseases. We are collaborative, creative, and experienced professionals and we're 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's like to be a part of our team: www.mirumpharma.com.

Position Summary

As an Intern on the Regulatory Affairs 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 5-6 week assignment, 40 hours/week, paid internship.
* Housing costs will not be reimbursed.
* This will require you to be on site in the Foster City, CA office for the duration of the 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 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 in RA department meetings.

Minimum Requirements:

* Undergraduate or Graduate student in a scientific discipline.
* Good command in English (written and spoken).
* Basic knowledge of healthcare industry and strong passion for pharmaceuticals. Basic understanding of pharmaceutical regulations (e.g. FDA, EMA) is an advantage.

Required Skills:

* Passion to learn.
* Organized, responsible, resourceful, and detail-oriented.
* Strong written and oral communication 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 environment with a collaborative spirit.
* Given an opportunity to improve personal growth and development.

Application needs 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?

#LI-Onsite

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's 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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