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Senior Regulatory Affairs Consultant / Regulatory Affairs Lead

USA - Any Region - Home Based Date posted 06/12/2022 Job ID 73577BR

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

Parexel currently has an excellent opportunity for a Regulatory Project Leader/Senior Consultant with previous experience in Regulatory Affairs and past experience managing quality, on-time regulatory applications and filings. This Regionally Home Based position is part of our growing Regulatory Consulting Services Team and offers an amazing opportunity to join an industry leader in a field that continues to see tremendous growth and opportunity!

As a Regulatory Project Leader you will provide leadership to project teams and manage the day to day operations of domestic and international Regulatory projects. You will strive to achieve operational excellence through on time delivery that is within budget and to the highest quality with the goal to exceed client expectations.

Qualifications

Successful candidates must at minimum, possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at least 10+ years' experience working as a Regulatory Project Leader/Manager within a CRO (preferred), a Global Health Authority ie. the FDA, a Biotech or a Pharmaceutical Company. Past experience overseeing a cross-functional team involved in the creation of US Regulatory Submissions to include preINDs, INDs, NDAs, and/or BLAs is required.

This position also requires experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience in Regulatory Affairs related activities.

Successful candidates must also possess the following:

•The ability to build and sustain relationships
•Critical thinking and problem solving
•The ability to influence and lead teams
•Financial management skills
•Strategic thinking skills
•Attention to detail and commitment to quality
•Conflict management skills
•Consulting skills
•Contingency planning and risk management skills
•People management skills
•Excellent interpersonal, verbal and written communication skills
•Client focused approach to work
•A flexible attitude with respect to work assignments and new learning
•Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
•Proficient in local language where appropriate and profound working knowledge of the English language
•Proficient in Microsoft Excel, Power Point, MS Project and Word.
•Experience with Parexel systems is a plus
•Willingness to work in a matrix environment and to value the importance of teamwork.
•Experience with financials and managing project budgets

Up to approximately 20% Domestic and/or International Travel may be required in the future

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

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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