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Regulatory Affairs Consultant - Generalist

Canada - Any Region - Home Based Date posted 07/01/2021 Job ID 70808BR

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

Fabulous home-based opportunity in Canada for a Regulatory Affairs Generalist to join our team as a Consultant and work closely with one large dedicated client. The Consultant will provide appropriate regulatory tactical support, strategy, and guidance to Project Teams for the development of regulatory submission packages (ie. license renewals, investigator updates, market registrations, etc.) and be responsible for the overall quality of submissions; manages, reviews and organizes documents intended for submission to Health Canada and/or other Health Authorities to assure compliance with regulatory standards; work closely with client's RAL; and partner with the team in preparation for Health Canada and other Health Authority meetings.

Additionally, a Consultant must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, profound knowledge within a business context of what services Parexel Regulatory Consulting provides. A Consultant develops specialist knowledge of a particular subject matter or market.
Provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.
  • Provides guidance to project team members on technical/process issues
  • Ensures the timely performance of work within a project scope to the quality expectations of PC and the client
  • Anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.

Project Execution
  • Works within a team environment or individually based on the project needs
  • Works within broad project guidelines and facilitates issue and conflict resolutions
  • Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope
  • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
  • Leverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisions
  • Produces quality work that meets the expectations of PC (Parexel Consulting) and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
  • Manages small projects and may manage larger project engagements
  • Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support
  • Provides guidance to project team members, and acts as a mentor to junior staff
Consulting Activities and Relationship Management
  • Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
  • Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
  • Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
  • Facilitates client decision making by framing issues, presenting options and providing objective business advice
  • Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflict
  • Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
  • Acts as a trusted advisor to clients and/or project team on technical and/or process issues

Qualifications

  • Develops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
  • Interacts professionally at multiple levels including senior management within a client organization
  • Successfully penetrates executive management levels or other business units within a client organization
  • Facilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
  • Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
  • Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with management and account management
We are looking for individuals that have:
  • 5+ years’ experience in an industry-related environment; Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries
  • 5+ years of experience in General Regulatory Affairs with previous experience in the preparation and submission of applications to Health Canada which may include reviewing and/or writing sections of applications from a clinical, nonclinical, or CMC regulatory perspective
  • Previous small molecule experience is strongly preferred
  • Experience with Health Canada regulatory requirements is required
  • Familiarity/experience with FDA and/or European submissions is strong preferred
  • Experience with project lifecycle and management
Education - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred

Language Skills - At least fluent vocal and written English

The ability to travel 10-15% may be required

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