10 Jan, 2022

(Senior) Regulatory Affairs Manager - APAC - Remote

  • Admin
  • Remote
Full time Management Medical-Nursing Pharmaceutical Science

Job Description

SUMMARY: The Senior Manager, Global Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle and contributing to the day-to-day operations of the Regulatory Affairs Department.

 

RESPONSIBILITIES:

  • Provide expert regulatory advice and contribute to regulatory project work
  • Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
  • Develop and communicate technical expertise and best practices to ensure client deliverables
  • Liaise with the CSS &Regulatory Affairs Directors to compile progress and review of milestone of projects on a timely basis,
  • Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
  • Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database
  • Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements
  • Effectively communicate status of submissions with the Sponsor, Project Manager, CSSL, RCL, SCL, CRAs, Medical & Scientific Affairs staff
  • Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
  • Participate in the recruitment selection process as required
  • Provide training, coaching and mentoring to other members of staff and line manage other members of staff (including Managers)
  • Assist the Regulatory Affairs Associate Director in oversee the work of the Regulatory Affairs team, provide support and develop/maintain departmental tools
  • Deputise for the Regulatory Affairs Associate Director as required
  • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

 

OTHER SKILLS AND ABILITIES:

  • Clearly, proven leadership and organizational management skills are essential attributes
  • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
  • Excellent written and verbal communication skills to clearly and concisely present information
  • Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meeting
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

 

REQUIREMENTS:

  • Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Previous experience within the pharmaceutical/CRO industry

Remote Status

100% Remote | Work From Home

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