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Senior Specialist  Regulatory Science & Advocacy Copenhagen Denmark,  

Lundbeck (company)


Posted on : 07 May 2017

Project Description

Description:
  •  We are looking for an experienced colleague with passion for regulatory aspects of medicines development to join company s Regulatory Science & Advocacy team as a Senior Specialist.
  • Regulatory Science & Advocacy is a six-person strong team. By fostering and integrating a regulatory science approach, we support Company's R&D organisation in achieving the best possible development strategies, differentiation and approval pathways. 
  • We use regulatory, competitive and payer intelligence to inform and challenge the drug development and regulatory strategy discussions. 
  • We work proactively with the external environment through partnerships, advocacy and engagement in multi-stakeholder platforms and trade associations. 
  • In addition, we are responsible for ensuring regulatory review of medical and marketing material as part of company s promotional compliance governance. 



Your job and key responsibilities
As a senior team member, you will be expected to lead, contribute to and further develop our department s deliverables to company s drug development activities, including: 
  • Integrating intelligence on regulatory and payer evidence requirements into regulatory development strategies - in close collaboration with relevant cross-functional teams.
  • Assessing the evolving global regulatory environment, and anticipate regulatory trends through a deep understanding of guidance, regulations and laws that impact company  in main territories.
  • Supporting the strategic preparations for late stage regulatory submission by collaborating with key colleagues (e.g. Regulatory Strategy Leaders) on intelligence needs and monitoring regulatory processes that are essential to development projects.
  • Monitoring and acting on innovative regulatory frameworks that can be assessed against the internal pipeline.
  • Engaging in external discussions and platforms on behalf of the company while ensuring that the organisation can utilize insights and networks to shape regulatory pathways.



We offer
  • This role is a rare opportunity to apply your regulatory experience to support drug development strategies while also engaging with the external environment to shape company s perspective on the regulatory framework of tomorrow.
  • The Regulatory Science & Advocacy team s remits and place in the organisation necessitates wide cross-functional collaboration, providing you with a unique possibility to gain insights into the pharmaceutical value chain while also creating possibilities to influence activities based on your expertise and creative ideas.
  • Finally, you will be part of a highly motivated team with diverse backgrounds, a team that has a strong culture of sharing knowledge and challenge each other in order to deliver the best possible quality.



Qualifications
Our preferred candidate has the following personal and professional qualifications: 
  • Life science education.
  • Detailed knowledge of US and EU (centralised) regulatory frameworks, with knowledge of other regions being an advantage.
  • In depth understanding of the global drug development value chain, including forward looking trends for regulatory, market access and payer framework conditions.
  • Track record of supporting / providing added value to drug development strategies and/or shaping regulatory pathways.
  • Strong professional network in the external regulatory environment.
  • A natural team player who is highly motivated by interacting with colleagues across functions. 



About Us: 
  • Our company  is a global pharmaceutical company specialized in psychiatric and neurological disorders.  
  • For more than 70 years, we have been at the forefront of research within neuroscience.  
  • Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.  
  • An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. 
  • Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders  we call this Progress in Mind.  
  • Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales.  
  • Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries.

Locations

Region Hovedstaden Copenhagen

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