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Consultant - Regulatory Intelligence / Regulatory Policy Analyst

USA - Any Region - Home Based Date posted 08/12/2019 Job ID 54219BR

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

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

Do you have a passion for Regulatory Affairs and Product Development? Incredible attention to detail? Superior research and information gathering experience? Excellent communication skills? An interest in CNS and Oncology therapies?

If so, Parexel Consulting has an amazing Regulatory Intelligence / Regulatory Policy Analyst Consultant opportunity that is dedicated to one global client.

As a Regulatory Intelligence / Regulatory Policy Analyst Consultant, you will:
  • Regularly search pre-defined data bases using pre-defined search terms for new and up-dated regulations and regulatory guidance documents and provide a listing plus high level summaries of the most critical findings (daily and weekly)
  • Perform competitor searches for products/projects being conducted by client
  • Maintain a list of up-coming conferences pertinent to client
  • Search for non-compliance letters or notices for client suppliers and provide a regular report
  • Keep a data base of new/updated regulations and guidance’s that are out for comment to industry and coordinate review and comments from client
  • Perform ad hoc requests for searches on specific topics
  • Inform client immediately of any findings directly affecting client business
  • Coordinate cross functional teams within the client to develop, establish, and facilitate the commenting process on guidances/policies
  • Lead the internal process to identify policies/guidances that require escalation/commenting, coordinate obtaining SME impact assessments/comments/feedback, facilitate comment collection/assimilation, and help develop company messaging to share either with the working groups in PhRMA or with the Health Authorities

Qualifications

To ensure success, you will have:
  • At least 4 years of regulatory affairs experience with previous experience in regulatory intelligence
  • A minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
  • Project management / leadership experience
  • Excellent interpersonal and intercultural communication skills, both written and verbal
  • Client-focused approach to work (Quality)
  • Results orientation
  • Teamwork and collaboration skills
  • Consulting skills
  • Critical thinking and problem-solving skills
  • Proficiency in local language and extensive working knowledge of the English language
The ability to travel @10%

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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