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Assoc Manager, Regulatory & Start Up (Fsp)

3+ years
Not Disclosed
10 Nov. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills:

Job Description: Supervisor, Local Regulatory Activities

Job Overview

The role involves supervising a local team responsible for regulatory activities, ensuring day-to-day operational objectives are met. This includes mentoring, coaching, and workflow coordination to maintain high performance and compliance with organizational policies and regulations.


Essential Functions

  1. Team Supervision

    • Oversee the delivery of local regulatory activities in line with organizational policies and applicable regulations.
    • Responsibilities include planning tasks, assigning duties, assessing performance, guiding professional development, rewarding and disciplining employees, and resolving employee-related issues.
  2. Recruitment and Onboarding

    • Participate in hiring processes by reviewing candidates and conducting interviews.
    • Ensure new employees are effectively onboarded and trained for their roles.
  3. Training and Resources Management

    • Ensure staff have the necessary materials, system access, and training to perform their job responsibilities.
    • Oversee the execution of training plans, including reviewing standard operating procedures (SOPs) and organizing practical training.
  4. Resource Allocation

    • Assist in assigning team members to clinical research projects, considering their skills, training, and experience.
  5. Quality Management

    • Monitor the quality of work delivered by the team, conducting regular reviews and evaluations of outputs.
    • Ensure team members meet defined workload and quality metrics, reporting findings to clinical operations management as required.
  6. Operational Coordination

    • Track team progress and ensure adherence to timelines and organizational goals through regular reviews and reporting.

Qualifications

  • Education:

    • Bachelor’s Degree in a scientific discipline or healthcare-related field (preferred).
  • Experience:

    • A minimum of 3+ years of relevant experience in Regulatory & Start-Up, Site Activation, or Site Management.
    • Prior experience in team leadership or management roles at a formal or project level.
  • Skills and Competencies:

    • Advanced proficiency in English.
    • Strong leadership, communication, and team-building skills.
    • Excellent organizational, problem-solving, and decision-making abilities.
    • Ability to mentor and coach team members effectively.
    • Familiarity with regulatory requirements and clinical trial processes.

This role offers the opportunity to lead a dynamic team while ensuring the efficient and compliant delivery of local regulatory activities. Successful candidates will play a pivotal role in supporting clinical research initiatives.