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