20 beste Stellen als bachem – aktuell auf Personalsuche

Manager Regulatory Affairs 100% (f/m/d)
Bachem Holding AG —Bubendorf, BL
- 100%
- Homeoffice
- Doktorat
- Englisch
- Forschungserfahrung
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- Bachelor
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Process Engineer Materials Management (a) 100%
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- 100%
- Microsoft Office
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Lab Technician QC - IPC (a) 100%
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- 100%
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Head Technical Documentation Sisslerfeld (a) 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Doktorat
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5 Tage
PI Server Data Historian Engineer (a) 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Englisch
- C++
- JavaScript
4 Tage
Head Facility Management Site Development (a) 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Microsoft Office
11 Tage
Storage Technician / Logistiker/in EFZ Inbound Technical (a), 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Englisch
SAP Solution & Implementation Lead (a), 80 - 100%
Bachem Holding AG —Stein AG, AG
- Homeoffice
- Englisch
- Forschungserfahrung
- Master
- Pensionskasse
21 Std.
Project Director Grossprojekte (a), 100%
Bachem Holding AG —Bubendorf, BL
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HSE Manager BSF Site Development 100% - Sisslerfeld(a)
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- 100%
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- Pensionskasse
Lab Technician QC-Late Phase 100% (a)
Bachem Holding AG —Bubendorf, BL
- 100%
- Englisch
Storage Technician Bereich Tankfarm (a) 100%
Bachem Holding AG —Bubendorf, BL
- 100%
Spezialist Reinigungsvalidierung (a) 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Master
11 Tage
Storage Technician Production Supply (a) 100% im Schichtbetrieb
Bachem Holding AG —Bubendorf, BL
- 100%
Director GSCM Network & Demand Center (a), 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Homeoffice
- Microsoft Powerpoint
- Microsoft Excel
- Management-Erfahrung
- Pensionskasse
Senior Commissioning & Qualification (C&Q) Lead (a), 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Homeoffice
- Englisch
- Forschungserfahrung
- Master
- Pensionskasse
CMMS Specialist - Maintenance & Engineering
Bachem Holding AG —Vionnaz, VS
- 100%
- Microsoft Excel
- Englisch
- Bachelor
Automation Engineer/Project Engineer: Digital Manufacturing and Data Lab 100% (a)
Bachem Holding AG —Bubendorf, BL
- 100%
- Forschungserfahrung
- Windows
- Bachelor

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Manager Regulatory Affairs 100% (f/m/d)

Bachem Holding AG -
Bubendorf, BL

Jetzt bewerben

Details zur Stelle

Festanstellung | 100% | Pensum: 90-100%
vor 1 Tag

Leistungen

Zusätzliche Urlaubstage

Qualifikationen

Doktorat
Englisch
Forschungserfahrung
Master
Personalführung
Bachelor
Kommunikationsfähigkeit
Deutsch

Vollständige Stellenbeschreibung

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our Regulatory Affairs (RA) team, we are looking for a (Senior) Regulatory Affairs Manager (permanent position, 100%, f/m/d).

You will take full responsibility for your assigned projects/tasks while benefiting from working within a highly motivated and innovative team.

Your tasks

Representation of RA in projects, including discussions and negotiations with the customers during the whole product lifecycle, i.e, from pre-clinical to marketed.
Close cross-functional collaboration with a high diversity of internal stakeholders.
Development and tailoring of convincing regulatory strategies.
Delivery of regulatory advice to internal and external stakeholders.
Hands-on writing and review of regulatory documents and dossiers in accordance with customer requirements and applicable regulatory rules and guidelines. The documents may have different backgrounds, e.g.,
Life-cycle phase from clinical Phases I-III or market purpose (e.g., NDA)
Peptide and oligonucleotide APIs
Target markets, e.g., US, EU, JP, CN, BR
Coordination of responses to authority requests in close collaboration with our customers.
Steering of site-overarching initiatives for improvement and innovation while proactively anticipating challenging situations.
Management of internal and external stakeholders to reach regulatory objectives while demonstrating high degree of integrity, reliability, resilience, tenacity, openness and collaborative spirit.
Coaching other RA members, as well as actively contributing to the knowledge-building and -transfer within the team.

Your profile

University degree Master and/or PhD with focus on Natural Sciences (Chemistry, Pharmacy, or similar field).
At least 5 years of professional experience in an RA function. Experience with regulatory requirements for drug substances is a plus.
Strong communication and collaboration skills supporting successful and efficient exchange with internal stakeholders, customers, and regulatory agencies based on a business mindset.
Experience in supervising complex projects and tasks and in establishing regulatory strategies.
Flair for creating high-quality output ranging from convincing presentations to on-point drug substance CMC sections of regulatory dossiers.
Critical thinker with a lot of curiosity and a knack for creative solutions.
Fluent and persuasive in English (C1) – German as a plus.

Our offer:

An empowered key position in an exciting, challenging, and highly dynamic environment that guarantees a wide range of activities.
You will join a team of international specialists that will help nurture your professional growth.
Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction.
Employee development through internal and external training opportunities.
Modern terms of employment and attractive fringe benefits.

Interested?

We look forward to receiving your complete application package (e.g., motivation letter, CV, testimonials, diploma) online via our Application Portal.

At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.

Jetzt bewerben

Erweiterte Suche

bachem Jobs

Manager Regulatory Affairs 100% (f/m/d)

Operator Support Team Manufacturing (a)

Quality IT Systems Administrator (a), 100%

Process Engineer Materials Management (a) 100%

Lab Technician QC - IPC (a) 100%

Head Technical Documentation Sisslerfeld (a) 100%

PI Server Data Historian Engineer (a) 100%

Head Facility Management Site Development (a) 100%

Storage Technician / Logistiker/in EFZ Inbound Technical (a), 100%

SAP Solution & Implementation Lead (a), 80 - 100%

Project Director Grossprojekte (a), 100%

HSE Manager BSF Site Development 100% - Sisslerfeld(a)

Lab Technician QC-Late Phase 100% (a)

Storage Technician Bereich Tankfarm (a) 100%

Spezialist Reinigungsvalidierung (a) 100%

Storage Technician Production Supply (a) 100% im Schichtbetrieb

Director GSCM Network & Demand Center (a), 100%

Senior Commissioning & Qualification (C&Q) Lead (a), 100%

CMMS Specialist - Maintenance & Engineering

Automation Engineer/Project Engineer: Digital Manufacturing and Data Lab 100% (a)

Ich möchte aktuelle Job-E-Mails für Stellen als bachem erhalten

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