What are the responsibilities and job description for the Summer Intern - Regulatory Affairs position at Karyopharm Therapeutics Inc.?
Role Overview & Key Functions:
If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between.
Our summer intern program, which will run from May 27th – Aug 8th, allows students to gain real world work experience in a high energy, collaborative work culture.
We are seeking a motivated and detail-oriented Regulatory Affairs Summer Intern to be part of our Regulatory Affairs team. This internship offers hands-on experience in regulatory documentation, submission preparation, and regulatory strategy while providing valuable insight into the regulatory landscape of drug development. The Regulatory Affairs Intern will gain hands-on experience in regulatory processes and learn how a Regulatory Affairs Team works together as an integral part of a pharmaceutical company. of a larger organization. This experience will enhance the Intern’s career prospects in Regulatory Affairs and related fields.
- Assist in the preparation, review, and submission of regulatory documents to health authorities (e.g., FDA, Health Canada, etc.).
- Conduct research on regulatory requirements, guidance documents, and industry trends.
- Support the maintenance of regulatory databases, tracking systems, and document management.
- Help compile regulatory dossiers and technical files for product renewals.
- Participate in cross-functional meetings as the Regulatory Ambassador and collaborate with departments such as Clinical Operations, Clinical Development, Quality, Pharmaceutical Sciences, etc.
- Perform administrative tasks related to regulatory filings and compliance as needed.
Candidate Profile & Requirements:
- Currently pursuing a Postgraduate degree in Regulatory Affairs
- Bachelor of Science degree in a relevant discipline such as Life Sciences, Pharmacy, Biochemistry, etc.
- Strong analytical skills and attention to detail.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and collaboratively in a fast-paced environment.
- Ability to communicate effectively, both orally and in writing.
- You have a strong interest in life sciences and are passionate about giving patients with cancer a chance to enjoy more of life’s precious moments.
- You feel a strong connection with our ICARE values (Innovation, Courage, Alignment & Accountability, Resilience, and Energy)
- You demonstrate enthusiasm for learning and a commitment to career development
Our Value Proposition:
At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!
