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Regulatory Affairs Consultant (Clinical Regulatory Writing)

USA - Any Region - Home Based Date posted 08/03/2020 Job ID post-40024449

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.


Are you an experienced Medical Writer who is looking to develop more technical writing skills and regulatory strategy exposure? If so, we currently have amazing opportunities to join Parexel's Consulting team as Clinical Regulatory Affairs Consultants and work alongside an incredibly talented client team!

As a dedicated partner to the client you will:
· Support Product Development RA Program Manager in his/ her responsibilities and assist the Product Development RA Program Manager to accomplish his/her tasks in meeting deadlines to achieve the projects, teams and departmental goals
· Prepare regulatory submissions in collaboration with the other disciplines in Product Development Research

- Support IND/NDA/BLA maintenance, support filings (INDs, BLAs, NDAs), support FDA meetings, support post marketing activities, representing regulatory at study team meetings, and coordinate answers to regulatory questions.
-Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Affairs-specific systems, processes,
- Establishes effective working relationships internally and externally with regulatory authorities.
- Documents meetings, teleconferences and other interactions/communications with regulatory authorities.
- Additional regulatory- and project-related support activities/services as requested by the client project lead(s)/team(s).
- Ensures compliance with SOPs and national regulations.

· Participates in and/or otherwise supports development and implementation of new or updated Product Development Research and/or Regulatory Affairs-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools as appropriate
· Completes other routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
· Participates in other special projects, as and when assigned, or otherwise requested
· Remain, at all times, fully abreast and apprised of evolving internal and external needs, processes and requirements as appropriate. Expected to share best practices within the department and cross functionally, identify and communicate opportunities for departmental enhancements and efficiencies
· Consistently complies with all governing laws, regulations, Parexel and client SOPs and other guidelines


    Successful candidate will have:
    · Previous experience in a clinical regulatory affairs focused role in industry.
    · Graduate (Bachelors) Degree required (life sciences disciplines strongly preferred)
    · Average of 5 years’ relevant clinical experience in regulatory affairs (US, EU, ROW); including extensive knowledge of clinical drug development, submission requirements and Health Authority interactions.
    · Knowledge of GxP, ICH, and other regulatory guidelines.
    · Knowledge of the drug development process and how other functions contribute.
    · Fully competent in teamwork/collaboration, achieving results, regulatory knowledge, operational excellence and organized.
    · Previous oncology is strongly preferred; however, exceptional candidates with other TA experience will also be considered.
    · Strong regulatory program management, leadership, teamwork, and communication skills.
    · Strong verbal and writing skills; proficient in MS Office apps.
    · Past experience supporting IND/NDA/BLA maintenance, supporting filings (INDs, BLAs, NDAs), supporting FDA meetings, supporting post marketing activities, representing regulatory at study team meetings, and coordinating answers to regulatory questions.

    A successful candidate also has:
    · Impeccable ethics. Demonstrates, or has proven abilities to demonstrate, high values & leadership competencies
    · Outstanding attention-to-detail and accuracy
    · Working knowledge of the multidisciplinary functions involved in pharmaceutical/biotechnology product development, e.g., clinical development, clinical operations, biostatistics, commercial operations, etc.
    · Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on target and within-budget accomplishment of such
    · Good interpersonal, verbal communication and influencing skills: can influence without authority in a matrix setting
    · Strong written communication skills
    · Good business presentation skills: is comfortable and effective when presenting to others, internally and externally
    · Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
    · Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
    · Works well within teams and is effective in collaborating with others internally and externally

      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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