Regulatory Affairs Project Manager

Responsibilities

• Prepare and review regulatory submissions
• Provide regulatory strategy advice to internal and external clients
• Provide project specific Global Regulatory Affairs strategy, technical expertise and co‑ordination oversight for key client\’s projects
• Ensure quality performance for key / managed projects
• Liaise with the wider business globally to support global projects
• Extensive contact with people throughout the company, with other regulatory consultants, with clients and with the regulatory authorities
• Manage Project budgeting / forecasting
• Assist in identifying and recognising out of scope activities in a contract in a timely manner and liaise with Contracts & Proposals Team to follow through on all aspects of contract modification
• Ensure compliance with relevant organisational and Global Regulatory Affairs Standard Operating Procedures and Working Practice Documents

Experience :

• Advanced MS Projects user – essential
• Professional experience within Regulatory
• Proven people management experience
• Preferably a bachelor\’s or higher graduate degree in a science-related field
• Good knowledge of global / regional / national country requirements and regulatory affairs procedures
• Proven experience in at least one of the following areas; Authoring Chemistry Manufacturing & Control documents for post‑approval regulatory submissions, Development of product information for post‑approval regulatory submissions, Working within Regulatory Information Management systems and submission publishing for electronic submissions to regulatory agencies or Regulatory submission experience in marketing authorisation applications
• Expert knowledge of ICH and other global regulatory guidelines
• Excellent English language skills
• Good organisational and planning skills
• Ability to motivate and integrate teams and teach / mentor team members

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