Remote - Regulatory Planning Management /HQ Planner

Job Title: Regulatory Planning Management /HQ Planner

Location:  Remote or Rahway, NJ

Duration: Full Time Opportunity

Roles & Responsibilities:

• Facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant stakeholders
• Proactively and creatively problem-solves, makes effective and timely decisions while skillfully negotiating to resolve conflicts
• Assemble a cross-functional team and drive identification, planning, and execution of regulatory and safety submissions, with an end-to-end mindset
• Identifies, assesses and actively resolves or escalates where necessary any risks that could impact the successful completion of submissions
• Independently identifies gaps and proposes solutions and leads efforts to solve as appropriate
• Actively manages timelines and has a clear understanding of dependencies and critical path activities
• Ensures project data, including information used to maintain compliance and aid with submission planning, is accurately reported in databases
• For assigned products, works closely with the Regulatory Lead to assess the overall program and manages the sequencing of submissions as needed
• Proactively drives project teams, establishes appropriate level of urgency, and maintains focus on deliverables
• Actively leads and/or participates in continuous improvement activities including business processes, tools, systems, metrics and analytics
• Continuously develops and improves leadership and project management skill sets, understanding of drug/vaccine/biologics/device development, and regulatory practices

• Education Minimum Requirement - Bachelor’s Degree
• Ability to lead, influence and work effectively in a matrix organization
• Project Managing and/or leading cross-functional teams in regulatory affairs function, supply chain or other
• drug development function
• Effective at establishing clear goals and assigning responsibility in a team setting
• Effective team facilitation with ability to establish collaborative team environments
• Detail-oriented with the ability to understand the “big picture” and overall strategy of projects/programs
• At least 8 years of working experience within a pharmaceutical/healthcare/consumer care industry in a project
• management/regulatory affairs and/or pharmacovigilance/risk management function

• Knowledgeable in the management and successful delivery of regulatory submissions
• Advanced degree preferred (engineering or scientific discipline, MBA)
• Technically skilled in 1 or more project management methodologies (e.g. PMP, Sigma, Change Management,
• SCRUM etc.) and experience with associated toolsets (e.g. MS Project for project planning, Data analysis and
• reporting PowerBI);