Regulatory Affairs Consultant

3 days ago

Delhi, India Parexel Full time
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:

- Works effectively within a team environment- Works within broad project guidelines as directed by the Project Lead or Technical SME- With the guidance of the project Technical SME, demonstrates the ability to prioritize work to achieve specified project outcomes- Capitalizes on opportunities to improve one’s own performance and seeks feedback from the Project Lead and colleagues- Applies information provided by the Project Lead or senior colleagues to complete assigned project activities- Produces quality work that meets the expectations of project 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 with clear guidance and support from Line Manager- 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 under the guidance of the project lead and/or Technical SME- Delivers a limited range of consulting services within personal area of expertise under the guidance of the Project Lead and/or Technical SME- Completes assigned activities within project scope and objectives under the direction of the Project Lead and/or Technical SME- Identifies project and internal issues to senior colleagues and Project Lead and/or Technical SME- Interacts professionally at all working levels within a client organization and within PAREXEL- Identifies project and/or client needs to the Project Lead and/or Technical SME- Interactions result in clients expressing satisfaction with service provided

Business Development:

- Begin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)- Communicates potential new business lead to PC management and account managers

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- Defines self-development activities with the support of management in order to keep current within the industry

Skills:

↪ Relevant experience in Clinical Trial Regulatory Submissions.

↪Experience in managing clinical trial studies, playing Regulatory Leads for international trials, and exposure to the European market.

↪Expertise in handling the CTIS database and submitting EU CTRS is desirable

Knowledge and Experience:

- 8+ years of experience in an industry-related environment

Education:

- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

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