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Position: Group Associate Director I – Product Regulatory Affairs

Location: Bangalore, Karnataka

Job Description:

Provide leadership and line management of 10-15 regulatory professional staff. Take on responsibility as a subject matter expert or contribute to continuous improvement in an appointed area within the team or RPM community.

Accountabilities/Responsibilities:

  • Provide leadership and line management for 10-15 direct reports at junior levels, 60% of the time. Ensure the principles of performance management are used to develop staff to their full potential
  • Responsibility for development and continuous improvement of expert and/or process area as appointed by the Head RPM, 40% of the time.
  • Member of the Leadership Team for the Emerging Markets Regulatory Project Management (RPM) group and as such take part in the collective leadership of the group. Proactively contribute to the strategy, direction and efficient operation of RPM by continuously enhancing the RPM organization and operating model
  • Contribute to the development of the team in AZ Bangalore as a fully integrated operational delivery team for AstraZeneca’s mature brands.
  • Partner with the Lead-RPMs providing optimal RPM resourcing to the Global Regulatory Execution Teams.
  • Ensure adherence to and continuous improvement of standards and processes.
  • Actively and objectively collaborate with other members of RPM Leadership and Management Teams to deliver a robust global RPM talent management process for the RPM community.
  • Challenge direct reports to prepare and own specific, trackable Individual Development Plans (IDPs) that meet direct reports’ career development goals.
  • Contribute to the management of the budget, identifying budget priorities taking careful note of global portfolio growth, and business needs.
  • Ensuring full awareness of and adherence to AZ group policies as well as full implementation of Corporate Responsibilities.

General Accountabilities:

  • Provide line management for direct reports, agree on yearly objectives and give regular status updates
  • Recruitment, development, retention, and talent management of staff, including succession planning
  • Drive a culture of continuous improvement
  • Ensure cost-effective and flexible resource management
  • Influencing the image of the business externally
  • Promote identification of underlying barriers to success

Desired Skills and Competencies

  • Excellent written and verbal English communication skills
  • Cultural awareness
  • Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
  • Ability to work independently and as part of a team
  • Influencing and stakeholder management skills
  • Ability to analyze problems and recommend actions
  • Continuous Improvement and knowledge sharing focused
  • General knowledge of drug development
  • Thorough knowledge of the regulatory product maintenance process
  • Experience in line managing teams
  • Leadership skills, including experience leading multi-disciplinary project teams
  • Experience of working with people from locations outside of India, especially Europe and/or the USA
  • Resource Management
  • Staff development

Internal and External Contacts/Customers

  • Global Regulatory Leads (GRLs)
  • Regulatory Regional Leads (eg, US, EU, International RADs)
  • Lead RPM
  • Other related skill groups, eg, Global Regulatory Operations, Global Labelling Group, CMC Regulatory Compliance, Patient Safety
  • Other internal R&D functions
  • Operations/Manufacturing organization (CMC post-approval)
  • Marketing Companies/Local affiliates
  • Other AZ functions (HR, Legal, Commercial Regions)
  • Health Authorities
  • External Collaboration partners
  • External professional and regulatory organizations.

Last Date: 14th Aug 2020

Qualification: B.Sc/B.Pharma or Comparable

Experience: Minimum of 13 years regulatory experience within the biopharmaceutical industry, including license maintenance, labeling and publishing and of working across a range of markets, including regulated markets

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