Global Regulatory Affairs Manager — CSL Behring
- Location
- Bern
- Contract
- full-time
- Posted
- Yesterday
Role overview
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 .
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 .
- Refer to local job documentation where applicable. About CSL Behring
- CSL Behring is a global biotherapeutics leader driven by our promise to save lives.
- 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.
Main responsibilities
- 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 . 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.
Key requirements
- 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.
Application process
- Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
- Create and compile of registration application documentation.
- Regulatory system, data entry and maintenance in/of regulatory systems.
- 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 .
Company and context
- 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.
Additional details
- Refer to local job documentation where applicable.
- 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/ .
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .
- To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer
Notes and original content
- Responsibilities:
- Qualifications:
- About CSL Behring
- Our Benefits
- You Belong at CSL
- To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
- Equal Opportunity Employer
Questions about this listing
What salary does CSL Behring offer for this role?
CSL Behring lists CHF 122'000 - 209'000 gross per year for this position in Bern. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does CSL Behring offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with CSL Behring during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Bern?
EU/EFTA residents living in the border zone of the country adjoining Canton Bern can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Bern's cantonal migration office or with HR during the application.
How do I apply for this position at CSL Behring?
Use the "Apply now" button on this page — it links directly to CSL Behring's original listing at csl.wd1.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
