Global Regulatory Lead

CSL Plasma Inc.; Bern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

CSL Behring in Bern, Switzerland is seeking an experienced Regulatory Affairs professional to plan, direct and monitor activities to obtain permits and approvals for current and future products. You will support development of consistent roles, oversee schedules and budgets, and maintain relationships with government agencies.

The role requires a life science or business degree and 3+ years in regulated pharma, with biologics experience preferred.

Qualifikationen

• 3+ years regulatory experience in the pharmaceutical industry.
• Biologics Regulatory experience preferred.

Aufgaben

• Plan, direct, and monitor regulatory activities to obtain permits and approvals.
• Develop consistent roles and work processes.
• Oversee plans, cost estimates, and schedules for approvals.
• Monitor regulatory developments and advise management on impacts.
• Maintain relationships with government agencies and regulators.
• Represent CSL Behring before regulatory or industry bodies.
• Prepare materials for legal counsel or external consultants.
• Create and compile registration documentation.

Kenntnisse

Regulatory affairs

Pharma industry

Biologics experience

Ausbildung

Bachelor's degree in Life Science or Business

Advanced degree (PhD/MD or 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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At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

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