Seagen

Summer Intern - Regulatory Affairs CMC

Internships - Bothell, Washington

Description

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found at www.seagen.com.

Summary:

The Intern, Regulatory Affairs CMC supports a global regulatory lead in executing against the global regulatory plan for a Seagen product. This position will support the Regulatory representative on cross-functional teams and assist in the development, preparation, and submission of regulatory documentation to global regulatory authorities. The intern will develop an understanding of the structure of and roles within a biotechnology company and of the drug development process.

Responsibilities:

• Work with assigned mentor to prepare, maintain, coordinate, and/or manage regulatory applications (e.g. IND/CTA, NDA/BLA) in accordance with applicable regulations
• Assist in the development, review, and submission of annual reports, as required
• Communicate regulatory expectations and timelines to clinical study teams
• Work with contract research organizations for ex-US regulatory submissions
• Participate in department meetings and activities
• Prepare final presentation on learnings from the program and provide feedback on internship experience

Qualifications:

• Bachelor’s degree in scientific discipline, and preferably currently enrolled full-time in a graduate program (M.S., Ph.D., PharmD, or M.D.)
• Excellent oral and written communication skills
• Strong technical/analytical skills to identify and solve problems independently
• Ability to manage multiple projects
• Willingness to work collaboratively
• Self-motivated, assertive, and self-confident
• Strong organizational skills
• Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality
• Enjoys working in a fast-paced, environment
• Ability to work in Bothell, WA

Note: This is an onsite, paid internship. This position is open to all students legally authorized to work in the United States. We are not able to offer visa sponsorship for internships. While housing is not provided by Seagen, we make every effort to connect fellow interns to arrange for joint housing and ride sharing.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

The hiring pay range for this position is $20 to $32 per hour based on skills, education and experience relevant to the role.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/02/2023