14 meilleures offres (bachem) (à pourvoir)

Manager Regulatory Affairs 100% (f/m/d)
Bachem Holding AG —Bubendorf, BL
- 100%
- Télétravail
- Niveau Doctorat
- Anglais
- Recherche
il y a 1 jour
SAP Solution & Implementation Lead (a), 80 - 100%
Bachem Holding AG —Stein AG, AG
- Télétravail
- Anglais
- Recherche
- Niveau Master
- Caisse de pension
8 h
Senior Project Manager Engineering (a), 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Anglais
MES System Engineer (a), 80 - 100%
Bachem Holding AG —Stein AG, AG
- De garde
- Télétravail
- Anglais
- Recherche
- Niveau Master
- Caisse de pension
il y a 4 jours
Electrical Engineer - Infrastructure & Production (a), 80 - 100%
Bachem Holding AG —Bubendorf, BL
- Anglais
il y a 5 jours
Senior Building Automation Engineer (SME BMS) - Large CAPEX Pharma Project (a), 100%
Bachem Holding AG —Stein AG, AG
- 100%
- Anglais
- Recherche
- Contrôleur programmable
il y a 14 jours
Senior Lab Technician QC - Late Phase 100% (a)
Bachem Holding AG —Bubendorf, BL
- 100%
- Anglais
- Recherche
- Contrôleur programmable
Senior Manager QA 100% (a)
Bachem Holding AG —Bubendorf, BL
- 100%
- Télétravail
- Gestion du personnel
- Anglais
- Microsoft Office
- Travail à domicile
- Caisse de pension
Manager QA - Engineering 100% (a)
Bachem Holding AG —Bubendorf, BL
- 100%
- Anglais
- Niveau Master
Senior Controller / Finance Business Partner Global IT (a), 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Microsoft Excel
- Anglais
- Niveau Master
Category Manager Capex (a) 100%, für den Bereich Bauleistungen
Bachem Holding AG —Bubendorf, BL
- 100%
- Anglais
- Microsoft Office
- Négociation
Lehrstelle als Laborant/in Fachrichtung Chemie EFZ (a)
Bachem Holding AG —Bubendorf, BL
- 100%
- Expérience en laboratoire
Lehrstelle als Chemie- und Pharmatechnologe/-in EFZ (a)
Bachem Holding AG —Bubendorf, BL
QA Engineering Manager (a), 100%
Bachem Holding AG —Bubendorf, BL
- 100%
- Anglais
- Niveau Master

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SAP Solution & Implementation Lead (a), 80 - 100%
Bachem Holding AG —Stein AG, AG
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides.
8 h

Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : bachem

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

Bachem Holding AG -
Bubendorf, BL

Soumettre votre candidature

Détails de l'emploi

CDI | 100% | Temps de travail : 90-100%
Il y a 1 jour

Avantages

Jours fériés supplémentaires

Qualifications

Niveau Doctorat
Anglais
Recherche
Niveau Master
Expérience en supervision
Niveau Licence
Compétences en communication
Allemand

Description complète du poste

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.

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bachem emplois

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

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

Senior Project Manager Engineering (a), 100%

MES System Engineer (a), 80 - 100%

Electrical Engineer - Infrastructure & Production (a), 80 - 100%

Senior Building Automation Engineer (SME BMS) - Large CAPEX Pharma Project (a), 100%

Senior Lab Technician QC - Late Phase 100% (a)

Senior Manager QA 100% (a)

Manager QA - Engineering 100% (a)

Senior Controller / Finance Business Partner Global IT (a), 100%

Category Manager Capex (a) 100%, für den Bereich Bauleistungen

Lehrstelle als Laborant/in Fachrichtung Chemie EFZ (a)

Lehrstelle als Chemie- und Pharmatechnologe/-in EFZ (a)

QA Engineering Manager (a), 100%

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Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : bachem

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