Head of Global Regulatory Affairs, Prescription Global Business Unit

Head of Global Regulatory Affairs, Prescription Global Business Unit

Galderma

La Tour-de-Peilz, Switzerland

Are you an experienced Regulatory Affairs leader with the ability to work in a vibrant, global environment and be a strategic thought leader within a business unit leadership team, partner with different functional internal stakeholders, as well as with regulatory agencies both in the United States and in Europe to influence and enable the achievement of our ambitious growth objectives?

The role is reporting to the Head of Prescription Global Business Unit and is a member of the BU Leadership Team.

Position deliverables:

Lead a multidisciplinary, international team of RA professionals and service providers to enable:

  • The development and approval of innovative products in all major markets.
  • The registration of new products in all additional markets.
  • The lifecycle activities for all marketed products worldwide.

Lead/animate/support the teams in the Rx GBU Global RA department to:

  • Establish the regulatory strategy, consultations with CAs, dossier preparation and approval for innovative development projects.
  • Deliver all necessary scientific/medical writing to support all projects and products.
  • Manage the RA IT support systems for document management, publishing, Regulatory Information Management and storage, and Regulatory Intelligence & Surveillance.
  • Compile and maintain CMC sections of investigational and commercial Rx products and specified OTC products.
  • Archive all regulatory documents (paper and electronic) and samples.
  • Support regulatory intelligence activities to assure compliance with new regulations, requirements and recommendations from relevant Competent Authorities (ICH, FDA, EMA …)

Management:

  • Responsible for evaluating, mentoring and developing team members.
  • Prepare and manage budget for all team activities.
  • Select and manage service providers as needed.
  • Manage Quality System requirements for team.

Education, Experience and Skills:

  • BSc, MSc, or Doctorate in a scientific discipline or a Pharmacist.
  • 15 + years in the Pharmaceutical industry including experience managing WW development projects and support for product compliance of commercial products.
  • Prior experience in management in an international environment.
  • Experience of development of biological products preferred.
  • Experience with the management of IT support systems and outsourcing.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Switzerland     Clinical Research     Manager and Executive     Medical     Regulatory Affairs     Galderma    

© 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