Senior Associate – Regulatory Project & Resource Mgmt (225-805)

The Senior Associate – Regulatory Project & Resource Management is a critical role designed to support and streamline regulatory projects within an organization. This position involves coordinating various tasks related to regulatory submissions and compliance, ensuring that projects are completed within set timeframes while adhering to stringent industry standards and regulations. This role is ideal for individuals with an eye for detail and excellent project management skills. The successful candidate will work closely with cross-functional teams to allocate resources efficiently and manage communication streams, ensuring that regulations are met with precision and timeliness. This position offers the opportunity for growth and development in a dynamic environment deeply rooted in regulatory affairs.

Responsibilities

• Coordinate and manage regulatory projects to ensure timely and efficient completion.
• Develop and maintain project timelines and resource allocation plans.
• Collaborate with cross-functional teams to align regulatory strategies and deliverables.
• Monitor project progress and address any issues or delays promptly.
• Conduct risk assessments for potential regulatory compliance issues.
• Prepare and review regulatory documentation and submissions for accuracy.
• Liaise with regulatory bodies to facilitate communication and approvals.
• Track and report on metrics related to project outcomes and resource utilization.
• Ensure compliance with all regulatory requirements and company policies.
• Support the development and implementation of process improvements in regulatory affairs.
• Assist in the training and mentoring of junior team members in regulatory processes.
• Organize and participate in regulatory meetings and project reviews.

Requirements

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field.
• At least 3-5 years of experience in regulatory project management.
• Strong understanding of global regulatory requirements and submission processes.
• Excellent organizational skills and the ability to manage multiple projects.
• Proficient in using project management tools and software applications.
• Exceptional communication skills, both verbal and written, with various stakeholders.
• Ability to work independently as well as collaboratively in a team setting.