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Job Details

Regulatory Strategy & Intelligence Director - Pain

Company: TEC Group International
Location:
Reference: CGRSIL4774
Closing Date: 26 Nov 17
Type: Permanent
Salary (£): Negotiable
Benefits: Exceptional package on offer including leading bonus structure and impressive relocation package if applicable

Job Summary:

The Regulatory Strategy & Intelligence Lead is a newly created position within this company and will allow you the opportunity to have a genuinely transformative role within a 5,000 employee company. This position will be responsible for creating and implementing regulatory policy and procedure internally as well as influencing the creation of regulatory policy from health authorities.

Requirements:

Official Title: Regulatory Strategy & Intelligence Lead/Director - Pain Portfolio

Location: Cologne area, Germany (Potentially some flexibility for part-time home based working)

Reports to: Senior Vice President and Head of Global Regulatory Affairs

The Regulatory Strategy & Intelligence Lead is a newly created position within this company and will allow you the opportunity to have a genuinely transformative role within a 5,000 employee company. This position will be responsible for creating and implementing regulatory policy and procedure internally as well as influencing the creation of regulatory policy from health authorities. You will also play a huge role in the setting of the Pain business unit’s strategic direction and execution through your input into due diligence activities, target indications etc.

Major duties, accountabilities and responsibilities 

  • Monitor trends and upcoming changes in the regulatory environment and evaluate their impact for the business. Develop and implement internal policy changes to take advantage of or lessen the impact of upcoming regulatory changes.
  • Provide strategic regulatory input and guidance in  the pre-due diligence phase (focusing on risks, mitigations and opportunities). The aim is to shape the direction of the Pain portfolio by ensuring due diligence resources are spent on viable products that will ensure the continued growth and expansion of the Pain portfolio in line with the devised strategy. 
  • Take a leading role in engaging with internal and external key stakeholders to drive and shape policy initiatives, making best possible use of networking/ advocacy opportunities. Build networks and play and active role in Regulatory networking groups, conferences, round tables etc. with the aim of having an input into the development of regulatory changes from health authorities.
  • In close collaboration with the hands on Regulatory Project Leads, participate in key  scientific advice meetings  and  coordinate overarching portfolio advice meetings
  • Deliver regular updates, educate and share knowledge in order to foster regulatory expertise and decision-making within the business.
  • Cooperate with subsidiaries, external partners and health authorities.
  • Work with the wider innovation team to shape the direction and strategy of the product portfolio, ensuring the companies continued long term success in this field.

The Person

  • University degree in Life Sciences
  • Several years of regulatory experience in leading regulatory R&D projects through all phases of development. Whilst this is not a hands on project focused role, knowledge and experience of leading complex regulatory projects is essential to allow you to make informed and educated decisions relating to the companies development strategy within the pain therapeutic area.
  • Broad  experience both pre- and post-authorization in  pain or related area, and across major territories (e.g. Europe, US) acquired in  industry and/or at  authorities
  • Detailed understanding of preclinical and clinical research (hands-on experience, guidelines, GXP), experience with biologics preferable but not essential.
  • Active in regulatory networking groups and access to a broad international regulatory network
  • Excellent communication, negotiation and conflict management abilities
  • International working experience, fluent English and working knowledge of German beneficial but not essential. This is a very multicultural business where the day to day working language in English.

 

Application and Interview Process

TEC Group will be compiling a shortlist of up to 5 candidates to recommend to the stakeholders at the company to fill this opening. You can expect to have a further in depth conversation with Christopher Gibson who will discuss the position and company with you at length, as well as discuss your current situation, skills & competencies and key achievements. Chris will be aiming to understand what value you can bring to this business and will use this information to compile the final shortlist of recommended candidates. The deadline for shortlist submission is 07th April 2017, however it may be presented before this deadline.

Should TEC Group plan to include your profile on the shortlist, you can be expected to be contacted by TEC Group to arrange a further conversation with Christopher which may take place via video conference or face to face. This meeting will take place in the days leading up to the deadline date. The interview process is expected to be thorough but nonetheless fairly fast-moving. This will include meeting with the Senior VP, Global Regulatory Affairs at the company as well as meeting some other senior stakeholders within the business including the CSO and other senior stakeholders in the innovation group.  The initial interview will be a telephone interview or face to face interview depending on your locations with the hiring manager and a representative from HR. The process will involve two trips to the global HQ in Germany 

We are expecting a decision to have been made and an offer to have been extended by mid-end of May 2017. 

Contact details: christopher.gibson@tecgroup.net or 0044 208 544 3421

Apply for this job: Regulatory Strategy & Intelligence Director - Pain

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
EC4R 2SU
England
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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