[Hiring] Senior Manager, Regulatory Portfolio @Syneos Health

Role Description

The Sponsor Dedicated Regulatory Portfolio Snr. Manager (GRO RPSM) will be responsible for overseeing regulatory affairs and project management within the pharmaceutical/biotechnology industry.

• Act with a drug development mindset, applying experience and expertise to understand customer needs.
• Collaborate with team members to innovate and help customers achieve their goals.
• Manage multiple Marketing Applications and/or LCM submissions simultaneously in various regions from submission to approval.
• Ensure compliance with global regulatory submissions and guidelines (FDA, EMA, ICH).

Qualifications

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs or project management.
• 7-10 years of participation in cross-functional project management activities.
• Expertise in global regulatory submissions.
• Prior experience with both small molecule and biologics.
• Strong organizational, communication, and problem-solving skills.
• Familiarity with filing submissions in various regions (Asia Pacific, Europe, UK, Switzerland, Russia, South America, Middle East, China, Japan, US).
• Strong PM fundamentals (meeting facilitation, timeline management, critical path assessment, risk and issues management).

Requirements

• PMP or similar certification preferred.
• RAC or similar certification preferred.
• Working knowledge with common project management systems required.
• Ability to multi-task and prioritize effectively.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management software (e.g., Smartsheet, ThinkCell, Office Timeline, MS Project).
• Proficiency with Lucid Chart or Visio (a bonus).
• Proficiency with Regulatory Information Management Systems, such as Veeva Vault RIM.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.