Regulatory Affairs Associate

Regulatory Affairs Associate

As a Regulatory Affairs Associate you will:

• Gain experience and exposure to groundbreaking programs and strategies for compounds in development and/or marketing products intended to address unmet medical needs in markets globally. Learn the laws, guidance, and regulatory requirements for drugs and combination products while being accountable to the organization's objectives. Accountability is the cornerstone of our culture. We demonstrate our compassion for patients and work hard to honor our commitment to those who depend on us to develop innovative therapies.
• Support innovative thinking and contribute to fresh innovative solutions in Regulatory Affairs. Innovation is our passion and mission as well as a fundamental requirement in our pursuit to create world-class medicines.
• Develop leadership and creative problem-solving skillsets, to become an inventive regulatory leader in the healthcare field of interest.
• As part of the two-year experiential regulatory leadership program, all Associates complete a project for presentation to the GRA Senior Leadership Team and other internal partners.

Qualifications

• Earned a bachelor's degree (B.S. or B.A.) from a 4-year University degree program in science, technology, or an engineering-related field. Examples include biomedical engineering, data analytics/applied statistics, quantitative modeling in biology, pharmacy, or other healthcare science. A strong academic track record is required.
• Some fundamental understanding of pharmaceutical drug development. Knowledge of current Food and Drug Administration (FDA) regulations, guidelines, and submission requirements are desired.
• Proven leadership capabilities in an organizational setting (campus/community activities) are desired.
• Able to work independently, as well as, be part of a group, with curiosity and flexibility.
• Be self-motivated, possess a "can do" approach, and courage to speak your voice and suggest innovative ideas.
• Be a creative problem solver, with an interest in exploring the international context of healthcare systems and technology contexts.