Group Associate Director I Product Regulatory Affairs

Job Description

• Provide leadership and line management of 10-15 regulatory professional staff. Take on responsibility as 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 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 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 organisation 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 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 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

Minimum Requirements Education and Experience

• Relevant University Degree in Science or related field
• Minimum of 13 years regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing and of working across a range of markets, including regulated markets
• General knowledge of drug development
• Detailed knowledge of the regulatory product maintenance process
• Experience in line managing teams
• Leadership skills, including experience leading multi-disciplinary project teams

Experience

• Experience of working with people from locations outside of India, especially Europe and/or USA
• Resource Management
• Staff development

Skills and Capabilities

• Excellent English written and verbal 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

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 organisation (CMC post approval)
• Marketing Companies/Local affiliates
• Other AZ functions (HR, Legal, Commercial Regions)
• Health Authorities
• External Collaboration partners
• External professional and regulatory organizations.

Description:Provide leadership and line management of 10-15 regulatory professional staff. Take on responsibility as 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 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 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 organisation 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 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 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

Minimum Requirements Education and Experience

• Relevant University Degree in Science or related discipline
• Minimum of 13 years regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing and of working across a range of markets, including regulated markets
• 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

Preferred Experience

• Experience of working with people from locations outside of India, especially Europe and/or USA
• Resource Management
• Staff development

Skills and Capabilities

• Excellent English written and verbal 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

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 organisation (CMC post approval)
• Marketing Companies/Local affiliates
• Other AZ functions (HR, Legal, Commercial Regions)
• Health Authorities
• External Collaboration partners
• External professional and regulatory organizations

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Keyskills :
financeadvisorycompliancereportingcustomer relationscost effectiveline managementemerging marketstalent managementregulatory issuesknowledge sharingproject managementcareer developmentdigital conversion