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Senior Specialist  Regulatory Science & Advocacy Copenhagen Denmark,  

Posted on : 07 May 2017

Project Description

Senior Specialist  Regulatory Science & Advocacy Location Region Hovedstaden City Copenhagen Department Drug Development Application deadline 24 May 2017 Description We are looking for an experienced colleague with passion for regulatory aspects of medicines development to join Lundbeck s Regulatory Science & Advocacy team as a Senior Specialist.Regulatory Science & Advocacy is a six-person strong team, which is based in Copenhagen. By fostering and integrating a regulatory science approach, we support Lundbeck 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 Lundbeck s promotional compliance governance. Your job and key responsibilitiesAs a senior team member, you will be expected to lead, contribute to and further develop our department s deliverables to Lundbeck 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 guidances, regulations and laws that impact Lundbeck 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 Lundbeck while ensuring that the organisation can utilise insights and networks to shape regulatory pathways.The position is based in Lundbeck s headquarters in Copenhagen, Denmark. Some travel can be anticipated depending on specific tasks and project involvement (10-20 days / year). We offerThis role is a rare opportunity to apply your regulatory experience to support drug development strategies while also engaging with the external environment to shape Lundbeck 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.QualificationsOur 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. Further informationFor further information, please contact Anders Bl


Region Hovedstaden Copenhagen

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