Amazing opportunity to join Parexel's Consulting team as a Senior Consultant and partner with one dedicated client!
PRIMARY DUTIES AND 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
QualificationsQUALIFICATIONS & EXPERIENCE:
· 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, submission requirements and Health Authority interactions
· 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
· Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, strong values & leadership competencies
· Outstanding attention-to-detail and accuracy
· Is regarded as a subject matter expert, is respected by others, and can effectively contribute to long-range product development and consistently leads cross-functional teams to successful results
· Strong business acumen: has in-depth knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
· Can effectively contribute to the development of disease strategies and plans
· Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget
· Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
· Outstanding written communication skills
· Strong business presentation skills: effective at summarizing and presenting the key considerations and decision points
· Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
· Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
· Proven track record of effective decision-making: makes good business decisions and exercise sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
· Strong financial acumen: proven abilities for planning, development and oversight of project budgets and other resources
· Strong cross-functional teaming skills: has consistently excelled in cross-functional teams and regularly demonstrated him/herself as a leader among peers
· Aptitude or proven ability to guide the work of others (lead and motivate others, prioritize and oversee work through to successful outcomes)
This is a home-based role which may require travel to client's US location.