Global Regulatory Affairs Manager

CSL Plasma Inc.; Bern; Hybrid; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

CSL Behring is seeking a Regulatory Affairs professional to lead planning and execution of regulatory activities in Switzerland. You will manage permits, licenses, and registrations while monitoring regulatory trends and advising leadership.

The role focuses on building strong government relationships and preparing documentation for counsel, with opportunities to work on biologics programs in a global biotherapeutics company.

Qualifikationen

• Bachelor’s degree in life science or business; advanced degrees are an advantage.
• 3+ years of regulatory experience in the pharmaceutical industry; biologics experience preferred.

Aufgaben

• Plan, direct, and monitor regulatory affairs activities to obtain permits and approvals.
• Support development of consistent roles and work processes.
• Oversee plans, cost estimates, and schedules; acquire permits and approvals.
• Monitor regulatory developments and advise management on impacts.
• Establish and maintain relationships with government agencies and authorities.
• Represent the organization before regulatory, legislative, or industry bodies.
• Prepare materials for legal counsel or external consultants.
• Create and compile registration application documentation.
• Regulatory system data entry and maintenance.

Kenntnisse

Regulatory affairs

Life science degree

Biologics experience

Pharma industry

Advanced degree advantageous

Ausbildung

Bachelor in Life Science

Business degree

Advanced degree (PhD/MD/MBA) advantageous

Jobbeschreibung

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 Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

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