Regulatory Affairs Consultant - Reg Ops / Reg Affairs Liaison

We currently have an amazing opportunity to join Parexel’s Regulatory Consulting Team as a Regulatory Affairs Consultant. This incredible role will draw upon your expertise daily as you drive the application and submission process forward as a liaison between Regulatory Publishing and Regulatory Affairs Managers for a dedicated Client Partnership.

A Regulatory Affairs Consultant must have previous technical publishing skills, regulatory knowledge, extensive eCTD experience, and an overall depth of electronic submission experience to allow them to serve as technical expert and lead the oversight of submissions and applications. QualificationsTo ensure success, you will have:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline is required, Advanced Degree Preferred

• 4+ years of regulatory publishing experience with strong eCTD experience

• Previous experience performing technical/regulatory document authoring within an automated platform

• Global regulatory submission/publishing experience

• Past experience preparing a regulatory technical dossier for each assigned product, which covers the main points outlined in the project overview

• The ability to write, review and update training materials, guidance documents, SOPs and work instructions on dossier processes

• Experience in authoring content as well as tracking, maintaining, collecting and preparation of both domestic and international regulatory dossiers

• Previous experience with US and Canadian Health Authority Submissions is required. European and ROW Heath Authority experience is a plus

• Demonstrated industry related project management experience and past experience overseeing a global team to achieve quality project deliverables within specified timelines

• 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 <15% Client’s office may be required in the future

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