Global Regulatory Affairs Manager

CSL Behring; Bern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

CSL Behring Switzerland seeks a Regulatory Affairs professional to plan, direct, and monitor activities ensuring permits, licenses, and approvals to conduct business and distribute products.

The role emphasizes staying aligned with evolving regulations, developing consistent processes, and maintaining strong relationships with authorities. A life science background and regulatory pharma experience are required.

Qualifikationen

• Bachelor degree in a Life Science or 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.

Aufgaben

• Plan, direct, and monitor regulatory affairs activities to obtain permits, licenses, certificates and approvals needed to conduct business.
• Support development of consistent roles and work processes.
• Oversee development of plans, cost estimates, and schedules; acquire necessary permits and approvals.
• Monitor regulatory developments and advise management on potential impact 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.
• Prepare materials for legal counsel or external consultants.
• Create and compile registration documentation.
• Regulatory system, data entry and maintenance in regulatory systems.

Kenntnisse

Regulatory affairs

Life sciences

Attention to detail

Ausbildung

Bachelor's degree in Life Science

Advanced degree (PhD/MD) in Life Science or MBA

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.

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 (https://www.csl.com/careers/your-well-being) .

You Belong at CSL

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

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement

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