What are the responsibilities and job description for the Global Regulatory Affairs Project Manager - GRAPM 0131 VG#0001 position at NavitsPartners?
Job Title: Global Regulatory Affairs Project Manager
Location: Upper Gwynedd, PA
Duration: 12 Months
Education:
- Bachelor’s degree in a technical, business, or science-related field (preferred).
Experience:
- Over 10 years in the pharmaceutical industry, with at least 5 years in Regulatory, Pharmacovigilance, Alliance Management, or Business Development.
- Strong project management, leadership, and problem-solving skills in a fast-paced environment.
- Ability to influence and operate effectively in an ambiguous, rapidly changing setting while maintaining compliance and quality standards.
- Expertise in virtual and in-person collaboration, facilitation, and leadership.
- Strong communication skills, including experience presenting to all organizational levels.
- Self-motivated, highly organized, and detail-oriented while maintaining a strategic perspective.
- Proficiency in data analysis and management, with experience synthesizing abstract milestones into centralized reports.
- Ability to manage multiple projects simultaneously, lead cross-functional teams, and facilitate effective meetings.
- Experience with change management principles and execution.
- Proficiency in MS Office (Word, Excel, PowerPoint, SharePoint) and familiarity with MS Teams and MS Project.
Position Overview
The Project Manager will oversee business processes and activities related to GRACS Business Development Execution. This role ensures the successful implementation and maintenance of regulatory activities associated with Company Business Development (BD) Agreements, including divestitures, mergers, acquisitions, licensing, collaborations, and partnerships.
Key Responsibilities
- Coordinate cross-functional GRACS teams to fulfill regulatory commitments and maintain compliance.
- Collaborate with Corporate Business Development, MRL Global Alliance Management, and the Integration Management Office to understand and execute partner agreements.
- Establish and onboard GRACS Integration or Transition Teams by recruiting Subject Matter Experts (SMEs) and defining integration/transition strategies post-contract execution.
- Serve as the GRACS Business Development Execution Lead, facilitating discussions, tracking progress, and reporting updates to leadership.
- Analyze integration challenges, identify risks, and develop solutions to ensure seamless execution of business deals.
- Implement a structured framework for understanding business partner operations and establishing best practices for collaboration.
- Develop functional alliance relationships, aligning expectations and processes for effective business deal execution.
- Drive continuous improvement in business processes for pre- and post-execution phases of BD Agreements.
- Act as the primary point of contact for ongoing alliance management issues related to GRACS activities
