CMC Regulatory Affairs Summer Intern

SUMMARY OF POSITION
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare diseases.
The Amicus Summer Internship Program is created to give students an opportunity for experiential learning in a corporate environment. This is a meaningful, mutually beneficial program where students will bring innovation and drive that will help us reach our goals. In turn, our highly skilled Amicus team will help students apply what they already know, and broaden their knowledge base.
This is a full-time (40 hours per week) paid internship that will run from May 16, 2022 until August 12, 2022.
ROLES AND RESPONSIBILITIES
The CMC Regulatory Affairs – Post Approval Summer Intern is responsible for:

• Research and consolidation of Chemistry, Manufacturing & Controls regulatory requirements information for global post approval variations and market specific requirements
• Assist CMC RA lead and CMC technical writer in the preparation of regulatory documentation for submission to global Health Authorities
• Research and develop gene therapy guide for IND CMC module 3 content for global markets

DEVELOPMENTAL, EXPERIENTIAL & EDUCATIONAL VALUE (for Summer Intern)

• Exposure to the broad scope of global Regulatory Affairs and specifically Chemistry, Manufacturing and Controls Regulatory Affairs and the role’s contribution to drug development and patients’ access to medicines as well as the interaction with cross-functional teams.
• Learn about the role of FDA, EMA and other global Health Authorities in the drug development process.
• Gain hands-on experience in preparing regulatory health authority correspondence and documents for submission to global health authorities.
• Raise awareness of the differences in regulatory requirements across regions.
• Opportunity to experience CMC technical product development and manufacturing functions in relation to regulatory affairs

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

• Candidates must be currently enrolled in an accredited college Undergraduate or Masters program
• Sophomore or higher with a GPA 3.0 or higher
• Legally authorized to work in the United States without needing sponsorship for employment now or in the future

IDEAL EXPERIENCE

• Preferably a rising junior or senior, working towards their undergraduate or graduate degree preferably in a science related field (ie. biology, chemistry, engineering)
• Completed at least 1-2 years of Biology/Chemistry/Engineering course work.
• Able to work remotely using MS TEAMS and other collaboration tools
• Intermediate experience using MS Office with a focus on Outlook, MS Word and Excel or similar applications
• Computer and technology savvy

LOCATION

• Preferred location is Princeton, NJ (with a hybrid work approach). It is expected that any remote workers are able to travel to the office up to 10% of the time

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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Job Type: Internship