(Senior) Regulatory Affairs Manager - APAC - Remote

Requisition Number: 3580

Position Title: Manager, Regulatory Affairs

External 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

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City:

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Employment Type: Regular

Community / Marketing Title: (Senior) Regulatory Affairs Manager - APAC - Remote

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Seoul, KR

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