Hozzászólva: Hálózati- és rendszer mérnök itt Észak-Brabant | Posted: |
We are looking for a Regional Safety Officer, MedInfo Lead - Regulatory Support - QA-deputy to join the team at CSL Vifor.
Responsibilities
Plan, direct, and monitor regulatory affairs activities so the organization has the permits, licenses, certificates, authorizations, and other approvals needed to conduct current and future business activities; and produce, sell, and distribute its goods and services.
Support development of consistent 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 the organization
Establish and maintain positive relationships with government agencies and other regulatory authorities
Represent the organization in matters before regulatory, legislative, or industry standards agencies so the organization's 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
Qualifications
Bachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD, MD) or Business (MBA) an advantage
3+ years regulatory experience in the pharmaceutical industry
Biologics Regulatory experience preferred.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
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We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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