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Senior Regulatory Affairs Consultant (Labeling Strategy)

USA - Any Region - Home Based Date posted 02/10/2020 Job ID post-40024517

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.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

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
  • "They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."

    Jasen - Consultant
  • "My experience so far with Parexel has been great! I had initially started at Parexel as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. Parexel is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "Parexel is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), Parexel offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "Parexel is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – Consultant


  • 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.


Exciting opportunity for a Senior Consultant, Labeling Regulatory Affairs to join Parexel's highly recognized Regulatory Consulting Team!

A Senior 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 PC (Parexel Consulting) provides. A Senior 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 work load and may prioritize the work load 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 conflicts. 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
•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 PC management and account management


We are looking for individuals that have:
•10+ years’ experience in an industry-related environment; Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries
•10+ years of experience in Regulatory Affairs with previous labeling experience to include past experience with developing NDA and/or BLA labeling strategy; past experience creating labels for NCEs; past experience with PLR; and past experience with Gx labels is also a plus
•Familiarity/experience with FDA interactions

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

Travel Required

EEO Disclaimer

PAREXEL is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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