Associate Manager

Location: Cambridge, Bedfordshire
Posted On: 9/6/2017
Job Code: Associate Manager
Job Description
• The Associate Manager, Regulatory Project Management provides project management support to the Rest of World (ROW) Regulatory Affairs team.
• The ROW Regulatory Affairs team is responsible for initial marketing applications, responses to regulatory questions, launch activities, variations and renewals.
• The Associate Manager, Regulatory Project Management performs a crucial role supporting these activities.

Specific Responsibilities:
• Working closely with cross-functional submissions teams including ROW Regulatory Affairs, CMC ROW Regulatory Affairs, Publishing and In-country Affiliates to ensure that submissions are prepared to agreed timelines.
• Leading meetings with the cross-functional submission teams to plan, coordinate, prioritize, and track submissions for the region and/or specific countries.
• Preparing and maintaining submission plans using MS Project.
• Preparing materials to support the team in developing submission strategies and prioritising activities, such as Visio process maps.
• Preparing and maintaining meeting outputs, action logs etc.
• Developing risk strategies and maintaining risk logs.
• Leading or participating in sub-teams supporting process improvement initiatives

• Demonstrated ability to discuss and negotiate critical and complex strategic issues with colleagues at all levels.
• Able to prioritise and manage their own activities and direct others as required.
• Able to articulate complex regulatory project management risks and issues with colleagues at all levels.
• Must be capable of leading a small team without direct line management responsibility.
• Must be comfortable with activities and priorities changing at short notice.

Essential Knowledge, Experience & Skills:
• Excellent organization skills and ability to work on several projects simultaneously, to tight timelines.
• Excellent verbal and written communication skills.
• Experience of using MS Project, MS Visio and MS Office, ideally to an advanced level.
• Attention to detail.
• Project management experience.
• Stakeholder management experience.

Desirable Essential Knowledge, Experience & Skills:
• Experience of collaborating using Skype for Business, or similar, with colleagues in other countries, particularly where English is not their first language.
• An understanding of pharmaceutical regulatory processes, manufacturing, change control and global distribution systems is an advantage.
• Experience within a regulated industry is preferred.
• Project management qualification such as PRINCE2 is desirable.
• A degree in a scientific field is preferred.
• Risk management experience.
Category:IT  code:new
Job Requirements
• Project Management experience essential for this role ideally 3 plus years.
• Responsibility for holding meetings, writing up notes and taking ownership over action plans.
• Must be comfortable dealing with colleagues/customers where English is not their first language.
• Strong MS office experience especially in Excel.

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Contact Details
Arti Tripathi
E-mail Address