Global Regulatory Affairs Manager

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.