Global Regulatory Affairs Manager Research Development & Sciences Global & Regional Regulatory Affai

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. #J-18808-Ljbffr CSL Vifor