Job Title Regulatory Affairs Intern Requisition JR000014746 Regulatory Affairs Intern (Open) Location Webster Groves, MO Additional Locations St. Louis, MO Job Description Summary Job Description The Company Mallinckrodt is a company united around a central pursuit – improving outcomes for underserved patients with severe and critical conditions. As a purpose-driven organization with a broad network and relentless determination, we create products, delivery systems and solutions for patients whose needs have not been met. Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty and generic pharmaceutical products and therapies. With locations in the US, Canada, Europe and Asia, culture is one of the most important aspects of our organization. Who we are at the core of our company - how we think, feel and work together means everything. We are anchored in our values of Patient Centricity, Innovation, Collaboration and Integrity. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. We are focused on listening for needs and delivering solutions. We provide medicines to address unmet patient needs, stemming from 155 years of using our unique strengths, experience and expertise to help improve people's lives. We know that we contribute to something that matters because we make quality products that impact patient lives. We have built an inclusive community and recognize the importance of every employee as a whole person – inside and outside of work. Our dynamic work environment provides unique experiences for employees to grow and develop. We are moving forward – come with us. The Program Mallinckrodt is offering an 11-week internship program, which provides an immersive experience in the world of pharmaceuticals. As an MNK Intern, you will have the opportunity to contribute to meaningful and impactful work that compliments the degree you are pursuing. Here, you will be able to apply what you’ve learned in the classroom to a corporate environment. In addition, our internship program is designed to include networking opportunities across the company, professional development workshops, and community service. Mallinckrodt is united around our mission – Listening for needs. Delivering solutions. Join us to get a sense of what it’s like to work at Mallinckrodt and gain the real-world experience you are seeking. Summary The Intern is responsible for assisting regulatory efforts to obtain approvals in order to market new generic drug products and provide ongoing regulatory support for all post-marketed projects and programs. Essential Functions + Helps to coordinate and communicate timelines and deliverables with Regulatory Operations, Labeling and other key departments to facilitate quality CMC and safety-related regulatory submissions, including ANDAs, Amendments, Annual reports, PSUR and post approval Supplements. + Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments. + Maintain current regulatory databases and produce various reports as needed + Utilize and support electronic document management system. + Assists with ongoing Regulatory Affairs projects and activities as needed. + Obtain regulatory knowledge of current guidelines and regulations. Minimum Requirements Education / Experience / Skills: + Student pursuing a bachelor or graduate degree in Life Sciences, Regulatory Affairs or related disciplines with at least three years of undergraduate study. Undergraduate degree in Chemistry, Biology, Pharmacy or other health related field preferrable. + Strong organizational skills + Ability to problem solve + Ability to work well with others + Excellent written and oral communication skills + Strong background using Microsoft Office tools specifically, Excel and Word, as well as Adobe Acrobat Organizational Relationship/Scope: + Will work closely with the regulatory submissions team, regulatory labeling, regulatory operations and clinical operations. + May work cross functionally with Pharmacovigilance, Formulations, Analytical, Manufacturing Site personnel to gather required regulatory documentation. + Reports to the Senior Director of Regulatory Affairs. This is a hybrid position that it is on site at our Webster Groves, MO location 2 days/week and remote 3/days week. At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Mallinckrodt and let’s do something dynamic together. Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)