Global Regulatory Affairs Manager

Syneos Health; Indiana; On-site; USD 110,000 - 150,000; Full time

Job summary

Syneos Health is seeking a Regulatory Manager in the United States (Indiana) to lead regulatory activities for multiple drug development projects. This role requires 10+ years in regulatory affairs, plus M.

Pharm or related Master’s degree, and strong leadership capabilities. You will prepare IND/NDA/MAA submissions, coordinate with internal teams and regulatory agencies, and ensure regulatory compliance across regions.

Qualifications

• Master’s degree or equivalent in science/ regulatory field with pharma experience.
• Proven ability to prepare/regulatory submissions (IND, NDA, MAA, etc.).
• Excellent written and verbal communication and customer service skills.
• Ability to work with multiple departments and deliver on tight timelines.

Responsibilities

• Lead day-to-day regulatory activities for assigned projects within timelines and budgets.
• Prepare regulatory submissions and briefing packages for agency meetings.
• Provide regulatory support in cross-functional project teams.
• Mentor team members and oversee training records.
• Ensure compliance with global regulatory requirements and company policies.

Skills

Regulatory affairs

Team leadership

Risk assessment

Stakeholder management

Strategic thinking

Project management

Life sciences knowledge

Regulatory intelligence

Education

Master's degree in science-related field

M. Pharm degree

Tools

Microsoft Office Applications

Job description

Syneos Health is seeking a Regulatory Manager in the United States (Indiana) to lead regulatory activities for multiple drug development projects. This role requires 10+ years in regulatory affairs, plus M.

Pharm or related Master’s degree, and strong leadership capabilities. You will prepare IND/NDA/MAA submissions, coordinate with internal teams and regulatory agencies, and ensure regulatory compliance across regions.