Job Description :

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
Required Experience & Skills:
  • 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
Desired Experience, Education & Skills:
  • 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);

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