Project Manager, Global Regulatory Affairs

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Role Details :
Global Regulatory Affairs (GRA) is responsible for ensuring the quality of documents and submissions to regulatory authorities globally in support of both investigational and marketed product activities. GRA is part of the Consulting group of Fortrea.
GRA is also responsible for authoring medical & regulatory documents and providing strategic input for projects as required.
This position is responsible for the timely preparation/co-ordination of Regulatory Affairs activities for a particular project and must work to high standards (governmental, Sponsor/Client, Fortrea and self) with minimal supervision. It is the responsibility of this position to ensure that all GRA deliverables for a project are prepared to the required standards by maintaining awareness of current regulatory standards related to drug submissions and clinical research. As a Project Manager, you will be accountable for communicating updates and issues to the team members as well as meeting the established timelines.
In this position, you will communicate daily with Regulatory Strategists, Medical Writers, invoicing and will serve as the main contact point to the client.
Responsibilities typically include developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. This position is focused on Regulatory Authority meetings and other pre-marketing authorization communication/documentation (e.g. Pediatric Plans, Orphan Drug Designation, Scientific Advice meetings, Pre-IND meetings, IND compilation, and End of Phase meetings), but you may benefit having both clinical trial Regulatory Affairs (CTA/IND submission) and post marketing authorization Regulatory Affairs experience.
This is a permanent, full-time, and home-based (you can also choose to work from the office) position. Depending on your seniority level, this role may be offered at Project Manager or Associate Project Manager level.
Summary of Responsibilities:

• Evaluate the impact of clinical/regulatory changes on assigned projects as well as Fortrea business operations
  
• Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval within project timelines
  
• Manage the preparation of high-quality responses to RFP/RFI
  
• Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
  
• Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations
  
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Fortrea and client requirements
  
• Propose and implement improvements to enhance the efficiency and the quality of the work performed on assigned projects
  
• Prepare and actively participate as operational lead in internal Project Review meetings
  
• Present at external and/or internal meetings
  
• Define and manage project resource needs and establish succession plans for key resources
  
• Create required project plans
  
• Implement and monitor progress against project plans and revise as necessary
  
• Serve as key client contact for assigned project(s)
  
• Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
  
• Prepare and deliver presentations in collaboration with relevant departments for new business as required
  
• Meet financial performance targets for assigned project(s)
  
• Manage client project metrics
  
• Perform other duties as assigned by management
  

Qualifications (Minimum Required):

• University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
  
• Understanding of, and ability to determine relevance of, governmental regulatory processes and regulations as pertains to drug regulation
  
• In lieu of the above requirements, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
  
• Detailed knowledge of financial control procedures (i.e. costing systems, time reporting)
  
• Working knowledge of project management processes, especially as it relates to clinical development
  
• Working knowledge of time and cost estimate development
  
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
  
• Broad knowledge of drug development process and client needs
  
• Excellent communication, organization and planning skills and attention to detail
  
• Fluent in English, both written and verbal
  

Experience (Minimum Required):

• Project Manager: At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development
  
• Associate Project Manager: At least 4 years of experience in the pharmaceutical industry with 2 years preferably in Regulatory Affairs or in Drug Development
  
• Experience in Regulatory Authority meetings and other pre-marketing authorization communication/documentation (e.g. Pediatric Plans, Orphan Drug Designation, Scientific Advice meetings, Pre-IND meetings, IND compilation, and End of Phase meetings)
  
• Demonstrated skills and competency in project management tasks and ability to work independently
  
• Experience in managing projects in a virtual environment
  
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
  
• Financial awareness and ability to actively utilize financial tracking systems
  
• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
  
• Demonstrated ability to lead by example and to encourage team members to seek solutions independently
  
• Ability to negotiate and liaise with clients in a professional manner
  
• Ability to present to staff at all levels
  
• Good computer skills with good working knowledge of a range of computer programs
  

Preferred Qualifications Include:

• Master’s or other advanced degree
  
• PMP certification
  
• Experience with EMA, FDA and other national regulatory authority bodies
  
• Working knowledge of Fortrea and the overall structure of the organization
  
• Basic knowledge of Fortrea sales and business development strategies and procedures
  
• Working knowledge of Fortrea SOPs
  

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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