Job Summary :

Otsuka’s internship program, Intern the Otsuka Way (InTOW), offers students a unique opportunity to gain hands-on experience and develop critical skills while contributing to meaningful projects. Interns will work alongside experienced professionals, learn about the complexities of the pharmaceutical industry, and gain insights into potential career paths. By combining practical experience with professional development, our program prepares interns for future success. Our internship program also includes instructor led trainings, a leadership engagement series, as well as insightful lunch and learns. 

Otsuka is a dynamic organization where motivated individuals come together to create new products for better health. We're driven by our purpose: defying limitations to improve lives. 

Deadline to apply: January 31, 2025.  

Interviews and offers: February through March 2025. 

Duration of internship: May 19, 2025, through August 11, 2025.  

Job Description  

Global Regulatory Affairs strategy leads provide strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Therapeutic Area Lead (TAL).  Leads identifies the need and obtain regulatory intelligence, research precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.  They translate complex pertinent global requirements and provide an assessment of the associated regulatory challenges to their respective teams, both internal and external as needed.   

The GRA intern will provide entry-level support to work alongside experienced professionals to gain experience in the field of regulatory strategy and global labeling. 

In a complex and competitively growing market, differentiating products being developed early on is essential to the success of the overall program.  The intern will support teams to implement new tools that are developed to optimize product labeling utilizing tools that can be innovative in addressing Otsuka’s needs 

The anticipated projects and initiatives include: 

Support in programs/initiatives to optimize or automate the collection of both available and competitor information with optimization of product labels. 

AND/OR 

Assist team members in the gathering and tracking appropriate reg intel for ongoing programs. 

The intern will coordinate and align with leads and local team members to ensure that the final output aligns with regulatory needs. 

The intern will assist in documentation of job aids, work instructions, quick reference guides, and tip sheets. 

The intern will create and maintain PowerPoint presentations. 

The intern will showcase his/her work by providing a summary (presentation) near the conclusion of the internship. 

Qualifications 

Minimum: 

Major or field of study to include Life Science /Business Analytics or similar 

Actively enrolled in an accredited college or university following the potential internship.

Can commit to full duration of internship program.

Additional Knowledge, Skills, and Abilities: 

Relevant coursework or experience 

Strong technical skills (e.g., software proficiency, data analysis, excellent communication and interpersonal skills 

Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility.

Demonstrate ability to work in a team environment.

Demonstrate ability to think creatively to solve complex problems.

Exhibits eagerness to learn and ability to learn quickly.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

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