Job Description
Our client a leading Multinational Healthcare company now require a Global Regulatory Affairs Project Manager
The Global Regulatory Affairs Project is responsible for the execution of the entire project lifecycle of EU driven Regulatory Affairs projects (for example Medical Device Regulations) across my clients Global entities, ensuring project delivery is focused on achieving global objectives, and in line with agreed business requirements and timelines
The Global Regulatory Affairs Project Manager will report to the VP of Regulatory Affairs
Responsibilities for Global Regulatory Affairs Project Manager:
? Determine project objectives, benefits, priorities, deliverables, implementation time lines and resource requirements
? Understand global direction, working closely with relevant Functions regionally and globally to ensure all projects are aligned and delivered in line with this direction.
? Liaise with relevant global and regional Functions to:
? Identify key stakeholders and understand regulatory / business requirements.
? Evaluate initial and additional project requirements.
? Become proficient in the inner workings of the company in order to determine the impact the project and changes associated with same will have on that particular Function.
? Work with local entities in identifying and resolving resource gaps where necessary.
? Effectively and efficiently schedule all the project activities and timelines to ensure the project objectives are met and delivered within the agreed timeframe.
? Monitor, track and communicate project progress in a structured and timely manner to Steering committee and key stakeholders.
? Lead and mentor project teams to ensure that each member meets his / her objectives within the scope of the project, escalating issues as appropriate.
? Anticipate regulatory and other obstacles/ risks and emerging issues throughout the project lifecycle and develop solutions with relevant functions and related teams, taking action as necessary to avoid delays.
? Be cognisant of departmental expenditure and budget.
? Meet and engage as directed with regulatory authorities (Competent Authorities, Notified Bodies and global regulatory agencies as required) to understand their needs and expectations.
? Work with the Director of Government & Regulatory Affairs (EMEA), Directors of Regulatory Affairs (Denmark and Ireland)) and global regulatory leadership to develop EU regulatory strategy.
? Ensure compliance to the Quality Management System and Business Processes.
Requirements for Global Regulatory Affairs Project Manager:
? Bachelor's degree in life sciences or chemistry. An advanced life science degree (e.g. MS, PhD) is preferred.
? Minimum of 10 years? experience in medical device or similarly regulated industry.
? Solid working knowledge of European regulatory environment
? Requirements include a thorough understanding of GLP, GCP, GMP, FDA and ICH guidelines.
? Proven Project Management skills and experience of running large cross functional, global projects.
? Strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills. Incumbent must have the ability to present facts and recommendations effectively in oral and written form.
? Proficient use of computers and use of Microsoft Office applications is required. Additional experience with databases and report writing is a plus.
? Willingness and availability to travel on company business.
Please send an up to date CV and cover note to John Reid at the RFT Group johnr@rftgroup.ie / 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.