Regulatory Project Lead – Life Sciences Solutions

Syneos Health; Mexico; On-site; PHP 350,000 - 650,000; Full time

Job summary

Syneos Health is seeking a Regulatory Associate - AdPromo to support the regulatory agency submissions, regulatory research, and product development lifecycle. Under supervision, the role focuses on creating submission documents for INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and other lifecycle activities.

The position emphasizes regulatory processes, collaboration with cross-functional teams, and adherence to global regulatory requirements in a fast-paced environment.

Responsibilities

• Build and institutionalize regulatory project management frameworks, tools, and best practices to enhance GRA-AP capability and effectiveness.
• Provide oversight of GRA-AP projects and portfolios, ensuring alignment with objectives and timelines.
• Coordinate and facilitate communication among regulatory affairs, project teams, stakeholders, and external partners to support project execution.
• Track project progress, materials, and deliverables, proactively identifying and resolving issues to maintain project momentum.
• Lead and participate in regulatory project meetings, including documenting minutes, updating project portals, and communicating outcomes to stakeholders.
• Perform administrative functions to support project teams and department operations.

Job description

Syneos Health is seeking a Regulatory Associate - AdPromo to support the regulatory agency submissions, regulatory research, and product development lifecycle. Under supervision, the role focuses on creating submission documents for INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and other lifecycle activities.

The position emphasizes regulatory processes, collaboration with cross-functional teams, and adherence to global regulatory requirements in a fast-paced environment.