AstraZeneca – Regulatory Affairs Group Director Job Vacancy at Bengaluru

AstraZeneca – Regulatory Affairs Group Director Job Vacancy at Bengaluru

Regulatory Affairs Group Director

 Bengaluru East, Karnataka, India 

JOB TITLE: Regulatory Affairs Group Director

CAREER LEVEL: F

Lead the way for a new breed of solutions-oriented Regulators

Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development

Be part of the team where you are empowered to follow the science

Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..

About Astrazeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

About The Team

We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.

About The Role

Description:

Provide leadership and line management of 10-15 regulatory professional staff. Lead as a subject matter expert or lead continuous improvement activities within function or x-functionally.

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 Senior Regulatory Affairs Group Director, 40% of time
• Member of the Leadership Team for the Emerging Markets Regulatory Affairs Management (RAM) group and as such take part in the collective leadership of the group. Proactively contribute to the strategy, direction and efficient operation of RAM by continuously enhancing the RAM 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 RAM 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 RAM Leadership and Management Teams to deliver a robust global RAM talent management process for the RAM 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 12 years of 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