Head of Global Regulatory Affairs, Prescription Global Business Unit(

Job Number:

 2000001M)

Description

 

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com    

 

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?

Then join us as the Head of Global Regulatory Affairs, Prescription Global Business Unit. The position can be based either in our Lausanne, Switzerland or Fort Worth, TX, United States offices.

Head of Global Regulatory Affairs, Prescription Global Business Unit

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.
  

  

Primary Location

: Switzerland-VD-La Tour-de-Peilz

Job

: Regulatory Affairs

Organization

: Galderma

Schedule

: Full-time

Job Posting

: Jan 17, 2020, 10:08:12 AM