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Job Details

Interim Regulatory Affairs AD

Company: Hobson Prior
Location: London
Reference: CM456654
Closing Date: 26 Sep 17
Type: Contract
Salary (£): On Application
Benefits: £75 - £90

Job Summary:

Our client a world leading pharma have a requirement for an interim Associate Director of Regulatory affairs on an initial 6 month basis

Requirements:

Our client a world leading pharma have a requirement for an interim Associate Director of Regulatory affairs on an initial 6 month basis 

 

The role is working within the oncology group and is focussed on MAA Centralised procedure for a development product

Key Job responsibilities:

• Collaborates to define, develop and lead global and/or regional strategies to maximize regulatory success towards achievement of program objectives. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements. 
• Provide regulatory expertise for multiple projects or one complex development project and / or marketed product(s) of responsibility. 
• Manages and trains direct reports and / or mentors team members, if required, to support scope of project work. 
• May be called upon to act as deputy to the Global Regulatory Lead, therapeutic area head and/ or Region regulatory head, and/or Marketed Products Head, attending internal leadership team meetings, as appropriate. 
• Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements. 
• Primary EMA contact with health authorities for project(s)/products of responsibility in regions of responsibility, or can delegate to staff and/or vendor with oversight. Informs the business.

 

EDUCATION/BACKGROUND
• BSc degree or equivalent in science; advanced degree preferred. 
• Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases. 
• Solid working knowledge of regulations and guidances governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role). A good understanding of basic regulatory requirements in emerging markets preferred. 
• Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. 
• Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies. 
• Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. 
• Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. 
• Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership. 
• Generally strong leader who is effective manager and is able to bring working teams together for common objectives. Able to mentor and develop skills of team members. 
• Experience in managing personnel a plus; experience managing relationships with CROs and/or contractors also preferred.

 

 

 

 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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