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Principal Regulatory Affairs Consultant

Italy - Any Region - Home Based Date posted 04/19/2022 Job ID 80965BR

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

We are now looking for a Principal or Senior Regulatory Affairs Consultant to join one of our exciting client dedicated project. In this role you will use your strong expertise in clinical development to support IND/NDA/BLA maintenance, support filings, support FDA meetings, support post marketing activities, representing regulatory at study team meetings, and coordinate answers to regulatory questions.

Role requirements:
  • Knowledge and experience on European regulatory strategy for compounds from early development through to MAA approval and beyond. Experience in MRP, DCP and CP submissions and EMA/national scientific advice
  • 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, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools
  • 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, SOPs and other guidelines

Qualifications

Skills and Experience required for the role:

• University Degree in a Scientific or Technical Discipline. PhD or other advanced degree (i.e. MBA) preferred
• 9 years + experience with expert level industry or regulatory knowledge; experience with a regulatory agency (such as FDA, MHRA) is a plus
• High-level consulting skills
• Critical thinking and problem-solving skills
• Project leadership and management knowledge
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work, results orientated
• Teamwork and collaboration skills
• Proficiency in local language and extensive working knowledge of the English language

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