Senior Regulatory Portfolio Manager – Sponsor Dedicated

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Provide project management support for regulatory activities within a growing Sponsor Portfolio.

• Engage exclusively with a single Sponsor.

• Contribute to the Regulatory Project Management Function alongside the Sponsor.

• Assist Global Regulatory Affairs initiatives.

• Oversee multiple Marketing Applications and/or lifecycle management submissions concurrently across various regions from submission to approval.

• Organize and facilitate meetings.

• Manage timelines and evaluate critical paths.

• Identify and mitigate risks and issues.

• Establish priorities in the face of conflicting demands.

• Execute additional tasks, duties, and responsibilities as directed.

⛳️ Requirements

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related discipline; advanced degree is preferred.

• At least 8 years of experience in regulatory affairs or project management within the pharmaceutical or biotechnology sectors.

• 7–10 years of involvement in cross-functional project management efforts.

• Proficiency in global regulatory submissions, with knowledge of FDA, EMA, and ICH guidelines.

• Experience in managing multiple Marketing Applications and/or lifecycle management submissions simultaneously across various regions from submission to approval.

• Background in pharmaceutical development and global regulatory submissions.

• Previous experience with both small molecules and biologics.

• Exceptional organizational, communication, and problem-solving abilities, with an emphasis on continuous improvement.

• Knowledge of filing submissions in regions including Asia Pacific, Europe, the United Kingdom, Switzerland, Russia, South America, the Middle East, China, Japan, and the United States.

• Strong fundamentals in project management, encompassing meeting facilitation, timeline management, critical path evaluation, and risk and issues management.

• Familiarity with common project management software.

• Capability to multitask and establish appropriate priorities amid conflicting demands.

• Proficiency in the Microsoft Office Suite and project management tools such as Smartsheet, ThinkCell, Office Timeline, and MS Project.

• Familiarity with Lucidchart or Visio is a plus.

• Expertise in Regulatory Information Management Systems such as Veeva Vault RIM.

• PMP or equivalent certification is preferred.

• RAC or similar certification is preferred.

• Equivalent experience, skills, and/or education may be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when appropriate.