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Senior Regulatory Affairs Strategy Consultant - Program Lead

Parexel International Corporation

USA - Any Region - Home Based

We currently have an amazing opportunity to join Parexel’s Regulatory Consulting Team as a Senior Regulatory Affairs Consultant for a large multinational dedicated client partnership!

As a Senior Regulatory Affairs Consultant you will partner with the client as a strategic program lead and: Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of client and regulatory requirements and guidelines, procedures and best practices, including compliance.For assigned project(s), as requested and monitored by the client project lead(s)/team(s), act as an accountable agent on behalf of client to the FDA and via client 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).QualificationsTo ensure success, you will have: Previous regulatory affairs experience in a clinical role in industry, previous exp with small molecule or biologic product experience is highly preferred.Graduate (Bachelors) Degree required (life sciences disciplines strongly preferred)Advanced Degree (post graduate; e.g. PhD, PharmD, M.Sc.) in a related field is strongly preferredAverage of 10 or more 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. · Level of direct therapeutic area experience is role dependent.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.Impeccable ethics. Outstanding attention-to-detail and accuracyIs 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 plansExcellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of suchStrong 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 externallyOutstanding written communication skillsStrong business presentation skills: effective at summarizing and presenting the key considerations and decision pointsConfident 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 mannerStrong negotiation skills: can effectively drive discussions and decisions toward desired end-resultsStrong cross-functional teaming skills: has consistently excelled in cross-functional teams and regularly demonstrated him/herself as a leader among peersAptitude or proven ability to guide the work of others (can lead and motivate others, as well as prioritize and oversee their work through to successful outcomes)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.

Job posted: 2022-05-26

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