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Manager RAC (Regulatory Affairs and CMC) - Job Opportunity at CARBOGEN AMCIS

Bubendorf, Switzerland
Full-time
Mid-level
Posted: May 25, 2025
On-site
CHF 120,000 - 160,000 annually (approximately USD 130,000 - 175,000). Switzerland offers premium compensation for pharmaceutical regulatory roles, particularly for positions requiring specialized biologics and ADC expertise. The salary reflects the high cost of living in the Basel region and the specialized nature of CMC regulatory affairs in the CDMO sector.

Benefits

Professional development opportunities in a leading CDMO environment that enhances career progression in the pharmaceutical industry
International exposure through work with global customers and regulatory authorities across multiple markets
Access to cutting-edge ADC and bioconjugate technologies representing the future of targeted therapeutics
Collaborative work environment with cross-functional teams spanning R&D, operations, and analytics
Opportunity to work on diverse customer projects providing broad industry experience

Key Responsibilities

Lead strategic regulatory document authoring and maintenance for critical registration submissions (DMFs, INDs, NDAs, BLAs, MAAs) that directly impact customer product commercialization timelines
Drive post-approval change management initiatives ensuring continued market access and compliance for commercial products
Provide expert CMC regulatory guidance throughout the entire product lifecycle from preclinical development to market launch, directly influencing customer success
Conduct comprehensive regulatory gap analyses that shape CMC development strategies and optimize regulatory pathways
Serve as primary regulatory interface with health authorities and customers, managing critical communications that impact product approval outcomes
Support internal regulatory projects that enhance organizational capabilities and competitive positioning

Requirements

Education

Master/Engineering or Ph.D degree in Biochemistry, Chemistry, Pharmacy or equivalent scientific discipline

Experience

At least 5 years experience in the pharmaceutical industry: 2+ years in an RA department combined with previous CMC (R&D, Operations, Analytics) function

Required Skills

Good understanding of regulatory affairs for drug substance with a focus on CMC development for Biologics and/or Chemical products Good knowledge of cGMP regulations Good knowledge of ICH guidelines and regulatory requirements for small molecules and biologics Team oriented, pro-active / problem-solving mentality, service-oriented mindset with flexibility to handle multiple tasks Good coordination and communication skills Fluency in English required Basic knowledge German is recommended Good sense of responsibility and reliability Knowledge of eCTD submission software (Docubridge) is an advantage
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Industry Trends

The pharmaceutical industry is experiencing unprecedented growth in antibody-drug conjugates (ADCs) and bioconjugates, with market projections indicating compound annual growth rates exceeding 15% through 2030. This trend is driving increased demand for specialized regulatory expertise in these complex therapeutic modalities. Contract Development and Manufacturing Organizations (CDMOs) are becoming increasingly strategic partners rather than service providers, with pharmaceutical companies outsourcing more critical regulatory functions to leverage specialized expertise and reduce time-to-market. Regulatory harmonization initiatives across global markets are creating opportunities for professionals who can navigate multiple regulatory frameworks simultaneously, particularly for biologics where regional requirements continue to evolve. The integration of digital technologies in regulatory submissions, including electronic Common Technical Documents (eCTD) and real-world evidence, is transforming how regulatory professionals approach documentation and authority interactions.

Role Significance

Typically manages regulatory aspects for 8-15 concurrent customer projects while collaborating within a specialized regulatory team of 5-8 professionals. The role involves matrix management across cross-functional teams including CMC development, quality assurance, and customer-facing project teams.
This is a senior individual contributor role with significant autonomous decision-making authority. The position requires independent management of complex regulatory strategies and direct interface with external stakeholders including health authorities and customers. The role bridges technical CMC expertise with regulatory strategy, indicating high organizational value and trust.

Key Projects

Leading regulatory submissions for first-in-human clinical trials of novel ADC therapeutics Managing complex post-approval change control processes for commercial biologics manufacturing Developing regulatory strategies for technology transfer projects from customer sites to CARBOGEN AMCIS facilities Supporting regulatory due diligence activities for customer mergers and acquisitions Implementing regulatory compliance programs for new therapeutic modalities and manufacturing technologies

Success Factors

Deep technical understanding of biologics and chemical manufacturing processes combined with regulatory expertise enables effective translation between technical capabilities and regulatory requirements Strong customer relationship management skills are essential for success in the CDMO environment where maintaining long-term client partnerships directly impacts business growth Adaptability to rapidly changing regulatory landscapes, particularly for emerging therapeutic modalities like ADCs where guidelines continue to evolve Project management excellence across multiple concurrent customer projects with varying timelines and regulatory requirements Cross-cultural communication competency for interfacing with global customers and regulatory authorities across different markets

Market Demand

High demand driven by the expansion of biologics and ADC markets, increased outsourcing to CDMOs, and shortage of professionals with combined CMC and regulatory expertise. The role's focus on emerging therapeutic modalities positions it at the intersection of high-growth market segments.

Important Skills

Critical Skills

CMC regulatory expertise for biologics is absolutely essential as this represents the core technical competency required for success in this role. The ability to translate complex manufacturing processes into regulatory-compliant documentation directly impacts customer product approvals and commercial success. Customer relationship management skills are critical in the CDMO environment where maintaining long-term partnerships drives business sustainability. The ability to serve as a trusted regulatory advisor enhances customer retention and expansion opportunities. Project management capabilities across multiple concurrent initiatives are essential given the dynamic nature of customer projects with varying timelines and regulatory requirements. Effective prioritization and resource allocation directly impact delivery quality and customer satisfaction.

Beneficial Skills

Knowledge of emerging digital regulatory technologies and data integrity requirements positions professionals for future industry evolution toward more automated and data-driven regulatory processes Understanding of global regulatory frameworks beyond ICH regions, particularly in emerging markets, provides competitive advantage as pharmaceutical companies expand their geographic footprint Business development acumen and commercial awareness enhance value within the CDMO environment where regulatory professionals increasingly contribute to customer acquisition and relationship expansion activities

Unique Aspects

Opportunity to work at the forefront of ADC and bioconjugate regulatory strategy, representing one of the fastest-growing segments in pharmaceutical development
Exposure to diverse customer projects spanning from innovative biotechnology startups to established pharmaceutical companies, providing comprehensive industry perspective
Integration of regulatory expertise with hands-on CMC development experience, creating unique value proposition in the specialized CDMO market
Direct involvement in shaping regulatory strategies for complex manufacturing processes and novel therapeutic modalities

Career Growth

Progression to senior management roles typically occurs within 3-5 years given the specialized expertise and customer relationship management experience gained in this position. The growing ADC market and CDMO sector expansion create accelerated advancement opportunities.

Potential Next Roles

Senior Manager or Director of Regulatory Affairs within CARBOGEN AMCIS or similar CDMO organizations Regulatory Affairs Director positions at mid-sized biotechnology companies focusing on biologics or ADC development Senior regulatory consultant roles specializing in CMC strategy for emerging therapeutic modalities Business development roles within CDMOs leveraging regulatory expertise to identify and develop customer relationships

Company Overview

CARBOGEN AMCIS

CARBOGEN AMCIS operates as a leading European CDMO with a strong focus on complex chemistry and biologics manufacturing. The company has established itself as a specialized provider for challenging synthetic chemistry and bioconjugate manufacturing, serving both emerging biotechnology companies and established pharmaceutical organizations.

The company holds a strong competitive position in the European CDMO market, particularly for complex small molecules and ADC manufacturing. Its multi-country presence and integrated service offering from development through commercial manufacturing differentiates it from smaller specialized providers.
The Bubendorf location serves as a key biologics and ADC manufacturing hub within the company's Swiss operations, benefiting from Switzerland's pharmaceutical cluster and proximity to major pharmaceutical companies in the Basel region. This location provides access to a deep talent pool and established industry networks.
The organization emphasizes technical excellence and customer partnership, with a culture that values scientific rigor and collaborative problem-solving. The CDMO business model fosters an environment of continuous learning through exposure to diverse customer projects and therapeutic areas.
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