20 annunci per il ruolo di application support - bern (recruiting in corso)

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CSL Behring —Berna, BE
- 100%
- Dottorato
- Bachelor
- Capacità di comunicazione
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Dalux —Berna, BE
- Inglese
- IT
DSL Linux DevOps
Universität Bern —Berna, BE
- Part-time
- Manutenzione
- Ricerca
- IT
Postdoc in Isotope Biogeochemistry
Universität Bern —Berna, BE
- 100%
- Dottorato
- Inglese
- Capacità di comunicazione
11 giorni
Director of Strategic Accounts
Tanium —Berna, BE
- Remoto
- IT
- Capacità di comunicazione
Candidatura rapida
4 giorni
CSV Professional in QC (f/m/d)
Bavarian Nordic —Berna, BE
- 100%
- Inglese
Office Admin/ Executive Assistant
Howden Group Holdings —Court, BE
- 100%
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Automatisierungstechniker
Mondelēz International —Berna, BE
- 100%
- Manutenzione
- IT
ERP Application Owner
Blaser Swisslube AG —Hasle, BE
- 100%
- Inglese
- Master
Production Process Operator (m/w/d)
Mondelēz International —Berna, BE
- 100%
- Manutenzione
Stagiaire universitaire
Administration fédérale - Département fédéral de l'intérieur DFI —Berna, BE
- Inglese
- Microsoft Office
- Master
Produktionsmitarbeiter/in
CSL Behring —Berna, BE
- 100%
- Competenze informatiche
SENIOR LEAD PRODUCT COMPLIANCE – PLB COMPLIANCE
IIC-INTERSPORT International Corporation GmbH —Berna, BE
- Competenze analitiche
- Guida veicoli commerciali
Digital Application Manager (alle)
SCHNEEBERGER AG Lineartechnik —Roggwil, BE
- Part-time
- Inglese
IT Project Manager
Bucher + Suter —Berna, BE
- 100%
- PMP
- Salesforce
- Inglese
13 giorni
Business Analyst IAM senior
Administration fédérale - Département fédéral de l'économie, de la formation et de la recherche DEFR —Berna, BE
- Inglese
- Master
Produktionsmitarbeiter:in Sterilabfüllung, Filling Line 2
CSL Behring —Berna, BE
- 100%
Manufacturing Professional/ Produktionsmitarbeiter FL VI (m/w/x)
CSL Behring —Berna, BE
- 100%
- Competenze informatiche
Programme Manager – National Research Programme (80–100%)
SNF FNS SNSF —Berna, BE
- 100%
- Parzialmente remoto
- Gestionale
- Dottorato
- Capacità di scrittura
3 giorni
Business Developer Public Sector (a)
AdNovum —Berna, BE
- Part-time
- Gestionale
- Inglese
- Master

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GRA CMC Specialist

CSL Behring -
Berna, BE

Candidati adesso

Dettagli della posizione

100% | Orario di lavoro: 90-100%

Qualifiche

Dottorato
Bachelor
Capacità di comunicazione

Descrizione completa della posizione

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Global & Regional Regulatory Affairs

Job Type: Full Time

Location: Bern, Bern, Switzerland

Employer Reference: R-275244

Job Description

Responsibilities:

Plan, support, and monitor regulatory affairs activities related to plasma derived medicinal products and human plasma as starting material to ensure compliance with global regulatory requirements and support current and future business activities.
Support the preparation, review, and maintenance of regulatory documentation for Plasma Master Files (PMFs), plasma source registrations, and related submissions for the European Union, Switzerland, and international markets.
Support preparation and submission of regulatory applications, variations, renewals, responses to health authority questions, and other regulatory filings related to plasma and biologic products.
Contribute to the assessment and implementation of regulatory requirements, guidelines, and emerging regulations impacting plasma derived products, plasma collection, and related manufacturing processes.
Support regulatory activities associated with plasma source lifecycle management, including new plasma source registrations, maintenance activities, and change control assessments.
Collaborate with cross functional teams to support regulatory strategy development, change management activities, technical assessments, and regulatory risk evaluations.
Support interactions with global regulatory authorities and contribute to the preparation of health authority communications, briefing materials, and scientific or regulatory discussions.
Support regulatory activities associated with U.S. plasma center licensing and maintenance activities, including coordination of documentation and support for regulatory inspections and submissions.
Contribute to scientific and technical regulatory evaluations related to plasma collection, plasma manufacturing processes, and biologic product lifecycle management.
Monitor regulatory developments and advise management and project teams on the potential impact of new or changing regulations on business activities and regulatory strategies.
Establish and maintain effective working relationships with internal stakeholders, regulatory agencies, and external partners.
Support development of consistent roles, work processes, regulatory procedures, and documentation practices across global regulatory activities.
Regulatory system data entry, maintenance, and management of regulatory information and documentation within applicable systems.

Qualifications:

Bachelor degree in a Life Science or related scientific discipline required. Advanced degree in a Life Science (PhD, MD) or Regulatory Affairs related field an advantage.
3+ years regulatory experience in the pharmaceutical, biologics, or biotechnology industry. Experience with biologics, plasma derived medicinal products, or blood/plasma related regulations preferred.
Experience supporting global regulatory submissions and interactions with regulatory authorities preferred.
Strong scientific, analytical, communication, and organizational skills with the ability to manage multiple projects and priorities in a global environment.
Ability to work collaboratively across functions and contribute to complex regulatory and technical discussions.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements.

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.

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Voglio ricevere gli ultimi avvisi Job Alert per il ruolo di application support nella seguente località: bern

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Job Description

About CSL Behring

Our Benefits

You Belong at CSL

Equal Opportunity Employer

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