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Head of Regulatory Affairs Israel

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Mid-level (2-5 years)
Work from: 
Israel, APAC

Offer summary

Qualifications:

Registered Pharmacist, 3+ years regulatory experience in the pharmaceutical industry, Previous experience as appointed pharmacist, Experience in matrix structures.

Key responsabilities:

  • Plan, direct, and monitor regulatory affairs activities
  • Maintain relationships with government agencies and regulatory authorities
CSL Behring logo
CSL Behring Biotech: Biology + Technology XLarge https://www.cslbehring.com/
7600 - 7600 Employees
About CSL Behring
CSL Behring, a Business Unit of CSL, is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 30,000 people, and delivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/vita and follow us on Twitter.com/CSLBehring. See our community guidelines: https://bit.ly/3QZbZeZ
See more CSL Behring offers

Job description

Responsibilities:

  • Plan, direct, and monitor regulatory affairs activities so we have the permits, licenses, certificates, authorizations, and other approvals needed to conduct our business activities; and produce its goods and services.
  • Dossier creation, submission and registration
  • Life cycle management of regulatory files
  • Ensure promotional material complies with regulatory guidelines
  • Manage external vendors
  • Support development of roles and work processes.
  • Oversee development of plans, cost estimates, and schedules. Acquire the necessary permits and approvals.
  • Monitor regulatory developments and advise management on the potential impact of regulations on our organization.
  • Establish and maintain relationships with government agencies and other regulatory authorities.
  • Represent us in matters before regulatory, legislative, or industry standards agencies so our interests are advanced.
  • Prepare materials for legal counsel or external consultants.
  • Create and compile of registration application documentation.
  • Regulatory system, data entry and maintenance in/of regulatory systems.
  • Collaborate with the Ministry of Health
  • You will report to the Regional Regulatory Cluster Lead

Qualifications:

  • Registered Pharmacist
  • Previous experience as appointed pharmacist
  • 3+ years regulatory experience in the pharmaceutical industry
  • Experience in matrix structures
  • Collaborative with hands-on attitude

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL!

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Pharmacy ExperienceRegulatory AffairsIn-LicensingRegulatory ComplianceRegulatory AffairsVendor ManagementLifecycle Management

Other Skills

  • Collaboration
  • Communication
  • Problem Solving
Are you interested?

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