Regulatory Affairs Project Manager

Advanced Resource Managers Ltd; Lisboa; Teletrabalho; EUR 60 000 - 80 000; Tempo integral

Resumo da oferta

A leading global CRO is seeking an experienced Regulatory Affairs Project Manager in Lisbon, Portugal. The ideal candidate will have advanced skills in MS Projects and professional experience in Regulatory affairs. Responsibilities include preparing regulatory submissions, managing project budgets, and providing strategic advice to clients. This role offers the flexibility to work remotely from anywhere in Europe for an initial 12-month contract.

Qualificações

• Professional experience within Regulatory.
• Proven people management experience.
• Good knowledge of global regulatory affairs procedures.
• Expert knowledge of ICH guidelines.
• Proven experience in regulatory submissions.

Responsabilidades

• Prepare and review regulatory submissions.
• Provide regulatory strategy advice to clients.
• Manage project budgeting and forecasting.
• Ensure compliance with organizational procedures.
• Liaise with other regulatory consultants and authorities.

Conhecimentos

Advanced MS Projects

Global Regulatory Affairs knowledge

Good English language skills

Organisational skills

Team leadership and mentoring

Formação académica

Bachelor's or higher degree in a science-related field

Descrição da oferta de emprego

Are you an experienced Regulatory Affairs Project Manager with exposure covering both EMEA and APAC regions? Do you have advanced skills in utilising MS Projects across previous roles? If so, this could be the perfect opportunity for you!

We are recruiting for a Regulatory Affairs Project Manager to join a globally leading CRO that provides comprehensive drug development and laboratory services to accelerate the delivery of new therapies to market.

The successful candidate will need to demonstrate strong skills with MS Projects as part of the interview process.

This role is offered on a contract basis initially for 12 months, you can be based remotely from anywhere in Europe.

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 recognizing 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 organizational 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