Intern, Regulatory Affairs Strategy

Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

We are seeking a highly motivated individual to join the BlueRock team as an Intern in our Regulatory Affairs Strategy team reporting into the Vice President of Regulatory Affairs and Medical Writing. This is a 3-month internship that will support regulatory activities in early development programs delivering on an assigned project, while becoming familiar with the regulatory affairs function and the biotechnology company culture. This opportunity includes learning and developing regulatory strategy for an assigned project, presenting learnings to the regulatory department, and forming and managing cross-functional relationships. Individuals will also develop awareness of the global regulatory environment for cell therapies.

Responsibilities

• Learn and present cellular therapy guidances and their applications to neurology, cardiology and ophthalmology programs;
• Lead an identified project to drive to completion supporting advancement of program(s);
• Develop solid knowledge of FDA regulations and ICH guidelines with other regions (EMA, LATAM, Etc)
• Flexibility and demonstrate urgency to resolve challenges in partnership with the regulatory affairs team;
• Collaborate cross-functionally with internal teams and subject matter experts to provide regulatory guidance and support throughout tenure;
• Oversee content development, organization, and coordination of cross functional regulatory submissions (e.g.,
• Contribute to regulatory department initiatives to develop procedures and working practices.

Minimum Requirements

• BS or MS degree in a scientific discipline, regulatory affairs or related field is required;
• Self-motivated with a desire to learn and contribute and able to work in a fast-paced environment;
• Strong interpersonal skills and the ability to collaborate effectively with various technical area experts.
• Excellent written and oral communication skills with attention to detail. Highly computer literate (Word, Excel PowerPoint), including formatting documents for regulatory submission.

All Emerging Talent roles are paid $28/hr.