Global Regulatory Affairs Project Lead

Global Regulatory Affairs Project Lead

Ferring Pharmaceuticals

Copenhagen, Denmark

The job

Your main responsibilities will be as follows:

  • Member of Global Project Core Team and chair of the Global Regulatory Project Team for microbiome projects in development for treatment of serious diseases;
  • Ensure collaboration with the global regulatory team in preparing global regulatory strategies, identifying regulatory opportunities and mitigating risks, developing competitive labels, preparing road-maps for global regulatory submissions and coordinating regulatory activities in collaboration with relevant team members;
  • Plan and manage meetings with Health Authorities worldwide. You will drive and lead the preparation of high-quality briefing packages and liaise with the Health Authorities and experts to obtain important scientific advices;
  • Ensure compilation, submission and approvals of CTAs and INDs for all clinical trial related regulatory activities as well as maintaining these throughout the product development phases;
  • For late stage projects, ensure submission and approvals of BLAs/MAAs in US, EU, Japan, China and other countries worldwide in collaboration with local regulatory colleagues;
  • Support regulatory Labelling, Non-Clinical & Clinical documentation for all market expansions, including responses to authority questions;
  • Perform review of clinical trial and safety documentation e.g. IB, DSUR, clinical trial protocol and report, DSUR, RMP and represent regulatory in clinical trial and safety team meetings.

Qualifications

The ideal candidate holds a degree in Life Science or Pharmacy, with more than 8 years’ experience with managing global regulatory activities and preferably with experience from working with labelling, clinical trials and other clinical and non-clinical regulatory activities.

You must have a proactive, strategic mind-set combined with the ability to plan and execute regulatory submissions. You have good negotiation skills as well as good judgment and decision-making skills. You are a true team player with a positive mind-set and a constructive attitude to drive results, and you are keen on working in an international corporate environment.

Excellent verbal and written communication skills in English are important.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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