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Job Details

Interim Director Regulatory Affairs - Consultant

Company: Planet Pharma Staffing Limited
Location: London- United Kingdom
Reference: RHS981
Closing Date: 10 Mar 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

If you are interested in finding out more please send a copy of your cv to Rowena at rhorn@planet-pharma.co.uk or feel free to call me directly on +44 203868 1012 I look forward to hearing from you!

Requirements:

My client, a leading Japanese pharmaceutical company in London is seeking a Interim Director Reg Affairs to join on a initial 3-6 month contract. This role is office based and seeks an experienced director. Long term they will be looking to bring on board a permanent hire. 

Key purpose: 

  • Lead Regulatory strategy in Europe on assigned projects 
  • Help to develop the regulatory strategy across multiple therapeutic areas as well as playing a major role in establishing a regulatory presence in the region 
  • Ensure the regulatory affairs plans meet the development and commercial goals and fit with Shionogi’s portfolio strategy 
  • Understand the scientific, medical and clinical development aspects of the company’s products in relation to the regulatory environment and advise and direct the company on the development, approval and commercialisation of the products that are developed, in licensed or acquired in the context of that environment

The responsibilities: 

  • Demonstrate proven regulatory expertise in participating or coordinating all due diligence opportunities and making recommendations to senior management 
  • Help develop and implement regulatory strategies to obtain product approvals with optimal labeling 
  • Contribute to building a regulatory presence in Europe and coordinate the regulatory support required to meet Shionogi’s corporate goals in the region 
  • Anticipate when and how regulatory issues may impact the business and diligently and quickly advise colleagues and management accordingly of the issue and proposed plan
  • Work on a collaborative basis both within Europe and globally becoming a fully functional member of a multi-disciplinary team, providing expertise on regulatory matters 
  • Work on special projects that require high level regulatory support & leadership for senior management

Education: 

  • A graduate degree in a scientific training 
  • MD, PhD, or PharmD or other advanced degree preferred but not essential

Skills and experience: 

  • Over 10 years of regulatory leadership and development experience within the pharmaceutical or biopharmaceutical industry 
  • Track record and demonstrated ability to lead cross-functional teams or major project across Europe or globally in multiple therapeutic areas 
  • Direct involvement in and knowledge of the preparation and filing of EU MAA and be familiar with CTD requirements and ICH guidelines 
  • Professional relationships and direct interactions with the EMA and other health authorities and regulatory agencies such as MHRA, Afssaps, BfArM, IPA and others 
  • Significant track record of success in obtaining product approvals in the context of EMEA submissions and panel hearings 
  • Substantial strategic regulatory mindset and demonstrated ability in representing his/her company to various regulatory bodies in both diplomatic and persuasive ways 
  • An ability to gain acceptance and build trust externally as well as internally across various functions and teams 
  • Solution oriented mindset with a “can do” attitude 
  • Knowledge and understanding of the role and interrelationship between functions, coupled with an ability to work effectively cross-functionally and cross culturally 
  • Right blend of skills, both technical and non- technical, to ensure optimal regulatory success is delivered for this growing business 
  • Capable of operating at different speeds or tempos, responding accordingly to the business, and recognition of the business culture which underpins the respective entities 
  • The deep technical expertise, with ability to elevate themselves out of pure technical perspective and make a solid contribution to strategic requirements
  • Ability to develop and maintain good relationships, gain the confidence of others, challenge views and present and argue a case without antagonising other people. 
  • Strong capability for managing and overseeing projects - broad awareness of the variety of requirements of a project/s and to manage varying priorities
  • Highly collaborative style, prepared to work effectively across functional, international, cultural lines - strong relationship capability, with personal effectiveness towards influencing and providing insights in a constructive and positive manner
  • Proven leadership skills and the regulatory affairs experience necessary to design and execute the regulatory affairs strategy across multiple programs 
  • The highest integrity and ethical standards.


 

Apply for this job: Interim Director Regulatory Affairs - Consultant

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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