Regulatory Affairs Manager

**When our values align, there's no limit to what we can achieve.**   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. **Key Accountabilities:** **Project Execution** * Typically works within a team environment but may work independently delivering services within their technical area of expertise * Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts * Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes * Capitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project technical lead * Seeks out information from previous projects, other client work or from colleagues to complete assigned project activities * Produces quality work that meets the expectations of project Team Lead and the client * May serve as a Project Lead for small scale projects or a Work Stream * Lead on larger projects When serving as a Project Lead * Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.) * Functions as the main client contact and ensures accurate project reporting is in place * Ensures that the project team delivers to meet the client expectations for quality and timeliness * Ensures that appropriate risk identification and issue-escalation procedures are in place * Ensures project specific training compliance of the project team * Ensures and/or manages project financials including provision of accurate revenue forecasts * Ensures that the project team understand and work to the scope of the contract * Identifies new opportunities through Change In Scope or add-on business from existing work * Ensures timely project close-out activities are completed **Consulting Activities and Relationship Management** * Follows and implements the organization’s consulting models and methodologies * Provides technical and/or business consulting services within personal area of expertise * Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability * Collaborates with colleagues and client to identify and resolve technical and process issues * Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate methods of executing project activities * Interacts professionally at multiple levels within a client organization and within Parexel * Proactively assesses client needs and develops processes and solutions to address issues * Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided * Interactions result in clients expressing satisfaction with service provided * May prepare and/ or deliver presentation with the support of senior colleagues * May deliver training * Mentor of junior staff * Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope **Business Development** * Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience * Communicates potential new business leads to PC management and account managers * May participate in project scoping calls and/or proposal preparation with the support of senior colleagues **Parexel-related Activities** * Meets established metrics as specified in scorecard on an annual basis * Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management * Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association) **Skills:** * Project management knowledge * Client-focused approach to work * Results orientation * Teamwork and collaboration skills * Consulting skills * Excellent interpersonal and intercultural communication skills, both written and verbal * Critical thinking and problem-solving skills * Proficiency in local language and extensive working knowledge of the English language **Knowledge and Experience:** * Several years of experience in an industry-related environment **Education:** * Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred