Director Global Regulatory Affairs Region EU Therapeutic Area (100%) (m/f/d)

Bern
04.05. | Cadre di­ri­geant | 100%

Director Global Regulatory Affairs Region EU Therapeutic Area (100%) (m/f/d)

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Stellenbeschreibung

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1600 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

For our location in Bern (Switzerland) or Marburg (Germany), we are looking for a

Director Global Regulatory Affairs Region EU Therapeutic Area (100%) (m/f/d)

Main Responsibilities and Accountabilities:

The Global Regulatory Affairs (GRA) Region EU Therapeutic Area Lead (TA Lead) is a member of the GRA Region EU Leadership Team and contributes to the vision and goals for GRA by:

  • Leads and oversees a GRA Region EU Regulatory Team for assigned Therapeutic Area.

  • Plans, drives and executes comprehensive, commercially and globally aligned regulatory activities within GRA Region EU that result in successful applications for products in assigned Therapeutic Area, from early development to Marketing Authorization (MA), and for any post MA submissions.

  • Contributes the regional regulatory perspective to the global regulatory strategy and aligns regional strategies with the global strategy within GRA throughout the product lifecycle for CSL Behring’s product portfolio.

  • Develops and leads the establishment and maintenance of high quality relationships with regional Health Authorities.

  • Assures a productive collaboration with key internal stakeholders, such as Region EU Commercial Operations and Affiliate Regulatory Affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies.

  • Contributes to regional regulatory intelligence to account for changes in relevant regulations and laws affecting CSL Behring’s business within Region EU and assesses these changes for impact to the business and CSL Behring’s product portfolio.

Qualifications & Experience:

  • A bachelor’s degree in Natural or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Regulatory Affairs advantageous.

  • At minimum 10 years’ experience in the pharmaceutical industry, preferably in Biologics in the areas R&D, Regulatory Affairs.

  • At least 5 years of regulatory experience in a regulatory authority-facing role, supported by additional pharmaceutical /industry experience.

  • Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities.

  • Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product.

  • Understanding of the principles of GMP, GCP and GLP.

  • Strategic and tactical thinking ability, complemented by a “hands on” operational approach and business planning orientation.

  • Ability to identify the ‘big picture’ and opportunities/major issues and link day-to-day tasks with long-term goals.

  • Demonstrated leadership ability. Keeps a team focused to deliver according to agreed milestones, can inspire and motivate while providing corrective feedback, if required.

  • Fluent written and spoken English

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.