Regulatory Submission Project Leader


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Are you an experienced regulatory affairs professional in the pharmaceutical industry? Do you have love for people management? Are you looking for an exciting challenge and lead a fast-growing team?

If you are, read on, we have a great opportunity for you to support one of the world’s most prestigious pharma companies by leading a new project. As a Project Leader, you will have the opportunity to combine your professional expertise and leadership skills by overseeing operational performance and quality of services delivered by team members within your project. You will be responsible for ensuring you meet or exceed the targeted objectives


• Apply your domain expertise of the in-scope process which is coming under your responsibility

• Be in-charge of day-to-day activities under your span of control.

• Provide technical expertise to the project team.

• Oversee activities of direct subordinates.

• Act as a point of contact for clients on operational delivery.

• Manage and coordinate across sub-processes.

• Provide regular status reports on budget recognition of the project to Project Manager.

• Manage documentation of all project related activities.

• Take ownership of all process improvement/change management initiatives by identifying opportunities for improvement and driving implementation of tangible opportunities

• Ensure that projects are completed within budget constraints and as per agreed timelines.

• Coordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issues.

• Maintain regular client connect to know the pulse of process & customers’ expectations

Leadership responsibilities

• People focused manager, encourages, and develops talents

• Host regular team meetings, one to ones and feedback sessions with the direct subordinates

• Pro-active performance management

• Ensure that associates understand the organizational goals and the unit strategy

• Identify critical resources and create succession plans

Quality/Process integrity

• Develop strategies in co-ordination with Team Leads and Project Managers to meet quality requirements efficiently and meet timelines set by the client.

• Monitor and track SLAs /Metrics on a project basis.

• Contributes to the development / review of appropriate business continuity plans, where applicable


• University Degree in Lifescience with minimum 4 years of regulatory affairs experience in a pharmaceutical company/clinical research organization

• 1-2 years of People management experience

• 1-2 years in Project Management experience in similar field preferred


• A career path

• A great diversity of cultures

• Language courses and training

• On-site relax & gym rooms

• Volunteering, sport and employee events

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