RESPONSIBILITIES:

• 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). 


• 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 best practices and tools as appropriate


• 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


• Leads other special projects, as and when assigned, or otherwise requested


• Consistently complies with all governing laws, regulations, client SOPs and other guidelines 
  
   

QUALIFICATIONS & EXPERIENCE:

• Previous experience in a Clinical Regulatory Affairs role in the industry.


• Bachelors Degree required (life sciences disciplines strongly preferred)


• Advanced Degree in a related field is strongly preferred


• 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


• Fully competent in teamwork (cross functional)/collaboration, achieving results, regulatory knowledge, operational excellence