Senior Regulatory Affairs Consultant - Clinical

Join Parexel Consulting and join a large dedicated partner relationship and who has a robust portfolio of approved products and amazing products in various stages development!

Our Regulatory Consultants use their expertise to partner with our clients in a variety of ways from developing clinical regulatory strategies; conducting gap analysis; preparing and/reviewing clinical sections of INDs and NDAs; partnering with client representatives to lead innovative programs; assisting in preparation and strategy for FDA and other Health Authority meetings!

The Senior Consultant will work closely with a dedicated client and serve as regulatory representative to Project Teams for assigned projects and provide regulatory tactical support and strategy. Ensures that clinical trials meet regulatory requirements as designed, recommends regulatory requirements for clinical and pre-clinical submissions to FDA, ensuring rapid and timely submissions to applications. Provides appropriate regulatory guidance to Project Teams for the development of regulatory submissions and responsible for the overall quality of submissions; manages, reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards.

As a Senior Consultant, you will draw upon your experience to:

· Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of client specific and regulatory requirements and guidelines, procedures and best practices, including compliance.

· For assigned project(s), as requested and monitored by the client's project lead(s)/team(s), act as an accountable agent on behalf of the client to the U.S. Food and Drug Administration (FDA) and via client's affiliates as applicable to work with ex-US Health Authorities - and lead and support regulatory team (cross sub functions of regulatory including documentation, CMC, submissions, labeling) or equivalent members for related activities.

· Provide experienced stakeholder management interfacing directly with internal stakeholders of various levels.

· Additional regulatory- and project-related support activities/Services as requested by the client project lead(s)/team(s). QualificationsAs a Senior Consultant* , you will have:

· Previous experience in a Clinical Regulatory Affairs role in industry

· Bachelors' Degree required (life sciences disciplines strongly preferred)

· Advanced Degree in a related field is strongly preferred

· Average of 10+ years’ relevant clinical experience in regulatory affairs (US, EU, ROW); including extensive knowledge of clinical drug development and submission requirements and Health Authority interactions. Qualified candidates with an average of 5-7 years’ relevant clinical regulatory affairs experience will be considered at the Consultant level.

· Knowledge and deep experience of the drug development process from IND/CTA opening through final product approval, and how other functions contribute to a regulatory submission (IND/CTA/IMPD, NDA/BLA/ANDA/MAA, etc.)

· Knowledge of GxP, ICH, and other regulatory guidelines; experience in providing regulatory assessments and guidance including considering precedence and relevant HA guidance through many project-level activities

· Fully competent in strategic agility, communication (stakeholder management), leadership, pharma drug development, organizational and business knowledge

· Previous respiratory, neuroscience, anti-effectives and oncology experience is preferred; however, exceptional candidates with other TA experience will be considered

· Experience in regulatory affairs (US, EU, ROW); experienced in submission requirements and HA interactions

· Strong regulatory program management, leadership, teamwork, and communication skills 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.