(Sr.) Regulatory Affairs Manager - EUROPE

Requisition Number: 3187

Position Title: Manager, Regulatory Affairs

External Description:

SUMMARY: The Manager, Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department.

 

RESPONSIBILITIES:

• Provide expert regulatory advice and contribute to regulatory project work
• Ensure accurate compilation, management and tracking of submissions
• Participate in business development activities preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets and attend bid defense meetings to meet business needs
• Develop department work practices and other company initiatives
• Liaise with the Regulatory Affairs Director to plan, organise, compile progress and submit regulatory submissions on a timely basis,
• Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
• 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 which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissions
• Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc…to ensure compliance with ICH GCP & country specific requirements
• Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff
• Comply with SOPs, ICH GCP and national regulations as applicable
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
• Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff
• Deputised for the Regulatory Affairs Director as required

 

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
• 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
• Ability to exercise sound judgment and make decisions independently
• Excellent self-motivation skills
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Expert knowledge of ICH GCP and the EU Clinical Trials Directive/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
• Expert knowledge of drug development

 

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:

State:

Employment Type: Regular

Community / Marketing Title: (Sr.) Regulatory Affairs Manager - EUROPE

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: Bucharest, RO

CountryEEOText_Description: