Sr. Associate or Consultant Regulatory Intelligence / Policy Analyst

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 clientMaintain a list of up-coming conferences pertinent to clientSearch 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 clientPerform ad hoc requests for searches on specific topicsInform client immediately of any findings directly affecting client businessCoordinate cross functional teams within the client to develop, establish, and facilitate the commenting process on guidances/policiesLead 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 AuthoritiesQualificationsTo ensure success, you will have:

At least 2 years of regulatory affairs experience with previous experience in regulatory intelligence for a Senior Associate role and at least 4 years of related experience for a Consultant roleA minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree PreferredProject management / leadership experience Excellent interpersonal and intercultural communication skills, both written and verbalClient-focused approach to work (Quality)Results orientationTeamwork and collaboration skillsConsulting skillsCritical thinking and problem-solving skills Proficiency in local language and extensive working knowledge of the English languageThe ability to travel @10%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.