Senior Regulatory Portfolio Manager – Sponsor Dedicated

🕒 September 9

🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 24%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Provide regulatory project management support to a growing Sponsor Portfolio • Work dedicated to a single Sponsor • Participate in the Regulatory Project Management Function with the Sponsor • Support Global Regulatory Affairs • Manage multiple Marketing Applications and/or lifecycle management submissions simultaneously across multiple regions from submission through approval • Facilitate and manage meetings • Manage timelines and assess critical paths • Manage risks and issues • Determine priorities when conflicts arise • Perform other tasks, duties, and responsibilities as assigned

🎯 Requirements

• 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 within the pharmaceutical/biotechnology industry • 7–10 years of participation in cross-functional project management activities • Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines • Experience managing multiple Marketing Applications and/or LCM submissions simultaneously and in multiple regions from submission to approval • Pharmaceutical development and regulatory global submissions experience • Prior experience with both small molecule and biologics • Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement • Familiarity with filing submissions in Asia Pacific, Europe, United Kingdom, Switzerland, Russia, South America, Middle East, China, Japan, and United States • Strong project management fundamentals, including meeting facilitation and management, timeline management, critical path assessment, and risk and issues management • Working knowledge of common project management systems • Ability to multitask and determine appropriate priorities when conflicts arise • Proficiency in Microsoft Office Suite and project management software such as Smartsheet, ThinkCell, Office Timeline, and MS Project • Proficiency with Lucidchart or Visio is a bonus • Proficiency with Regulatory Information Management Systems such as Veeva Vault RIM • PMP or similar certification preferred • RAC or similar certification preferred • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate