Senior Global Regulatory Affairs Manager, CMC - Advanced Therapy

Senior Global Regulatory Affairs Manager, CMC - Advanced Therapy

Ferring Pharmaceuticals

Copenhagen, Denmark

THE JOB

Reporting to Associate Director, Global Regulatory Affairs, CMC, your main responsibilities will be as listed below. You will be working with an innovative gene therapy project, which is new to the company and for which the regulatory strategy is currently being developed. We are looking for a strong candidate, who can actively drive and support the global project team in bringing this product to the market, including the following activities:

  • Responsible for the global regulatory CMC strategy for the gene therapy development project with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance;
  • Lead global CMC submission activities for the assigned project, while applying the global strategy into submissions;
  • Build and provide regulatory CMC expertise within advanced therapy to cross-functional teams such as the Global Regulatory Project Teams, CMC Teams, Product Teams and Launch Teams;
  • Perform regulatory impact assessment of CMC changes for the development project, ensure that adequate documentation is generated to support the change;
  • Plan and participate in Health Authority meetings in relation to CMC activities. In close collaboration with subject matter experts you will be responsible for setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans in relation to meetings with Health Authorities.

You will be working in an international environment and have interfaces with many different disciplines including other Regulatory disciplines, Global Pharmaceutical R&D, Product Supply, Ferring’s affiliates and development sites around the world.

YOUR QUALIFICATIONS

The ideal candidate holds a degree in life science or Pharmacy, with at least 7 years of global RA experience for a Senior position. Since gene therapy is a new modality in the portfolio, regulatory CMC experience with advanced therapy products is preferred. However, regulatory experience with biologics/biotech will also be considered.

You must have a proactive mindset and a desire to continuously develop and find innovative solutions to regulatory challenges, which you are able to communicate well verbally and in writing. In addition, you are well-organized and have the ability to plan, execute and meet deadlines. You have good negotiation skills and can deal with ambiguity. You are a true team player, an experienced user of IT (including MS Office), and are keen on working in a multicultural corporate environment.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

© EuroJobsites 2020

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

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2020

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

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies