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FSP - Regulatory Affairs Project and Data Manager

Romania, Remote Date posted 09/23/2022 Job ID R0000003875

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

We are currently looking for a client dedicated Regulatory Affairs Senior Associate who will act as a Regulatory Project and Data Manager (RPDM) .

In this you will work closely with Regulatory Matrix Teams and Early/Medicine Development Teams to provide Regulatory functional line planning support and resource management to active Rx and Vx projects, spanning Commit to Candidate (C2C) through post-approval R&D activities. You will own and provide active management of integrated Regulatory Development Plans.These plans will reflect the Global Regulatory Strategy for individual Vx and Rx projects.You will work alongside a more senior Regulatory Portfolio Manager to create the Plans, after which you will work independently to maintain the plans, ensuring they continue to reflect the Global Regulatory Strategy as it evolves over time.This includes adding appropriate Regulatory deliverables, updating timelines, manipulating the interdependencies and logic in the plan to ensure accurate timelines that drive key Regulatory milestones.

This role can be based in Poland, UK, Belgium or Italy - office or home based.

Key Responsibilities:

  • Independently use judgement, strict adherence to quality and process expectations, industry and regulatory standards and drug development experience to deliver high quality integrated Regulatory Development Plans (RDPs) based on input from GRLs and project teams on the overall development strategies associated with projects (asset by indication)

  • Responsible for maintaining integrated Regulatory Development Plan (RDP) for operationalizing the Global Regulatory Strategy (as defined by the GRL), ensuring regulatory deliverables, timelines, and resource needs are accurately captured for each phase of development

  • Provide Regulatory functional line planning support at the project level

  • Perform scenario planning through developing alternative planning schedules, for development team and portfolio decision making

  • Proactively partner with other functional plan owners/project managers from Medical, Safety, Clinical, etc., to ensure awareness of regulatory deliverables and alignment across all plan types within a project group

  • Support R&D Governance reviews at key stage gates in the development process; Ensure any requested data is complete, accurate, and fit for purpose for informing business decisions

  • With support from line managers/RPMs, as needed, build the associated schedules to drive Regulatory resource forecast estimates; forecast cost (EPE) and resource (FTE/IPE) associated with integrated plans

  • Partner with key stakeholders including RMT members and functional Project Managers, etc. to ensure plan schedule alignment to intended strategy

Skills and Experience required for the role:

  • University degree

  • 5 years of experience understanding of pharmaceutical business, drug development, and project management

  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives

  • Ideally possessing knowledge of Regulatory Affairs responsibilities from pre-IND through post-approval

  • Experience with project management principles and systems (e.g. Planisware), resource management and reporting features (e.g. Spotfire)

  • Demonstrated experience in a range of role essential skills (e.g., data analysis, problem resolution, enterprise-wide project management tools)

  • Ability to present data and visualizations based on the needs of the target audience

  • Project management experience, preferably in the pharmaceutical industry or in a regulatory environment

  • Fluent in English


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