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    Regulatory Affairs Associate

    Parexel
    0 -1 yrs. in PV / 1-2 yrs. in clinical practice years
    Preffered by Company
    Bangalore
    Not Disclosed July 5, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm, M.Pharm, PharmD, Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences Skills: Communication Skills, GCP guidelines, ICH guidelines, Interpersonal Skill, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Regulatory Affairs Associate

    Location:

    • Bengaluru, India
    • Additional Locations: Hyderabad, Telangana, India

    Apply Now: [https://jobs.parexel.com/en/job/bengaluru/regulatory-affairs-associate/877/67142745312?codes=JB_Indeed]

     

    Overview

    As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

    We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

    Success Profile

    Key Soft Skills and Interpersonal Traits:

    • Communicator
    • Detail-oriented
    • Problem-solver
    • Relationship-builder
    • Results-driven
    • Strategic

    About This Role

    Key Accountabilities:

    Project Execution:

    • Works effectively within a team environment
    • Works within broad project guidelines as directed by the Project Lead or Technical SME
    • Demonstrates the ability to prioritize work to achieve specified project outcomes with the guidance of the project Technical SME
    • Seeks feedback from the Project Lead and colleagues to improve performance
    • Applies information provided by the Project Lead or senior colleagues to complete assigned project activities
    • Produces quality work that meets the expectations of the project lead and the client
    • May serve as a Project Lead for small-scale projects or a Work Stream Lead on larger projects
    • As a Project Lead, with clear guidance and support from Line Manager:
      • Responsible for project planning and set-up
      • Interacts routinely with the assigned Project Specialist (PS) or Project Manager (PM) to control the project
      • Functions as the main client contact and ensures accurate project reporting
      • Ensures the project team delivers to meet client expectations for quality and timeliness
      • Ensures appropriate risk identification and issue-escalation procedures are in place
      • Manages project financials, including provision of accurate revenue forecasts
      • Ensures the project team understands and works 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
    • Completes assigned activities within project scope and objectives
    • 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
    • Ensures client satisfaction with service provided

    Business Development:

    • Begins networking within the industry (i.e., maintains contacts and relationships with clients once engagements are complete)
    • Communicates potential new business leads to PC management and account managers

    Parexel-related Activities:

    • Meets established metrics as specified in the 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 to stay current within the industry

    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

    • Initial 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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