Regulatory Affairs Associate Jobs

About The Position

Requirements

• Bachelor's degree in Business Administration, Information Management, Communications, Data Science, Life Sciences, or a related field.
• At least 5 years of experience in pharmaceutical, life sciences, or other regulated environments.
• Strong balance of innovation, strategic thinking, and operational execution within regulated and GxP environments.
• Strong change leadership, negotiation, consensus-building, and stakeholder management skills.
• Experience partnering with business stakeholders, IT organizations, vendors, and sourcing partners to deliver technology-enabled solutions.
• Organizational awareness and ability to influence and collaborate effectively across all levels of an organization.
• Proven success leading cross-functional, global, and matrixed teams to deliver business and technology initiatives.
• Knowledge of regulatory affairs and pharmacovigilance business processes, information, and systems.
• Excellent written, verbal, presentation, storytelling, and stakeholder-influencing skills.
• Skills in automation solutions, change management, cross-cultural awareness, data management, employee training programs, policy implementation, regulatory operations, stakeholder engagement, systems development lifecycle (SDLC), and vendor management.

Nice To Haves

• Strong business acumen and ability to understand complex regulatory information relationships.
• Experience with process improvement and change management methodologies, such as Lean Six Sigma.
• Ability to operate effectively in ambiguous environments and deliver results under aggressive timelines.
• Experience organizing enterprise innovation challenges, digital community forums, or similar innovation programs.
• Demonstrated ability to use Generative AI and large language models (LLMs) to solve business problems, including data preparation, model utilization, and generation of actionable outputs.

Responsibilities

• Drive adoption, engagement, governance, and business value realization for digital capabilities across GRACS.
• Partner with business stakeholders to identify opportunities, shape digital strategies, and deliver measurable outcomes.
• Serve as the primary liaison between business functions, technology organizations, and global stakeholders.
• Lead engagement strategies, stakeholder partnerships, use-case discovery, demand management, governance activities, and capability-building initiatives.
• Ensure digital investments align with business priorities and deliver sustainable impact.
• Support the transition of digital solutions from concepts to trusted, scalable capabilities embedded in day-to-day operations.
• Drive utilization, business value, and continuous improvement through stakeholder engagement, change management, communications, training, and performance monitoring.
• Lead cross-functional, global, and matrixed teams in delivering business and technology initiatives.

Benefits

• Medical, dental, and vision healthcare benefits.
• Other insurance benefits for employees and their families.
• Retirement benefits, including a 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.