Collegium Pharmaceutical Intern Regulatory Affairs Recruitment
Collegium Pharmaceutical Intern Regulatory Affairs Recruitment. Collegium Pharmaceutical is a specialty pharmaceutical company committed to being the leader in responsible pain management. For nearly two decades, Collegium has been focused on developing and commercializing new medicines for pain management that reflect our Core Values and our commitment to people suffering from pain, providers and our communities. The result of those efforts is a portfolio of meaningfully differentiated medications to treat moderate to severe pain.
Intern, Regulatory Affairs
Location: US-MA-Stoughton
Job ID: 2021-1449
Category: Regulatory Affairs & Quality Assurance
Overview
Looking to expand your knowledge beyond the classroom? Collegium’s C2C Summer Session enables and equips students to gain industry knowledge and hands-on experience outside of the classroom through mentorship from our passionate and experienced Collegium team! Collegium is committed to being the leader in responsible pain management. Come join the camaraderie of Collegium Pharmaceutical!
The Regulatory Affairs Internship position offers an opportunity for students to learn the skills and knowledge needed to become a practising Regulatory professional and gain valuable experience and knowledge of the processes and operations at Collegium with an insight into the biotech/pharmaceutical industry.
The Intern will work closely with the Regulatory Affairs team and other stakeholders to ensure successful implementation of regulatory strategies and timely submissions of critical regulatory documents to the Food and Drug Administration (FDA). With a “hands-on” approach, the Intern will be provided with instructions and then tasked with real-world assignments to meet regulatory requirements.
Responsibilities
- Learn about Investigational New Drugs (INDs) and New Drug Applications (NDAs) for pharmaceuticals.
- Learn about the eCTD structure
- Participate in the preparation of regulatory submissions to the FDA
- Conduct literature searches
- Perform regulatory intelligence studies
Qualifications
- Graduate or undergraduate student majoring in life sciences, healthcare, or related fields
- Familiarity with FDA regulations and ICH-GCP guidelines is preferred
- Excellent organizational ability and attention to detail
- Ability to handle and prioritize multiple assignments in a fast-paced environment
- Good verbal and written communication skills
- Ability to work well with others and to take direction well
- Minimum availability of 10-12 weeks during the summer of 2021
