JOB OPPORTUNITIES
We operate under a fully externalized model, partnering with CMOs for manufacturing and Quality
Control. Our portfolio includes 15 commercial products (oral solid dosage forms and sterile
injectables) across Europe and the Middle East. We are opening a new position, Senior Quality Control
(QC) Project Lead, to support the growing complexity of projects and strengthen analytical oversight
across projects.
Senior Quality Control (QC) Project Lead
This newly created role strengthens analytical oversight within project activities and supports the growing
complexity of our portfolio. Acting as a senior analytical expert within the MSAT department, you will work
as part of the QC team as a joint analytical counterpart, collectively ensuring scientific oversight of external
QC activities and contributing to cross-functional project planning. Together with the QC Manager, you will
define the most appropriate technical and operational approaches, while this role brings a particular focus
on project-related aspects such as timelines, coordination, anticipation, and budget management. The role
requires strong scientific expertise and a collaborative, project-driven mindset.
As a Senior QC Project Lead, you will contribute to the MSAT team, primarily at the Basel site, and report
to the Head of MSAT.
Key responsibilities
• Provide senior scientific oversight of analytical activities performed by CMOs
• Conduct thorough and critical reviews of analytical data, OOS/OOT investigations, and change
controls
• Contribute to analytical control strategy definition across the product lifecycle
• Ensure alignment between QC activities, project timelines, and regulatory milestones
• Support cross-functional project teams by integrating analytical considerations into global planning
• Contribute to risk assessments (nitrosamines, elemental impurities, impurity strategies)
• Contribute to stability strategy design and data evaluation (ICH conditions)
• Contribute to analytical methods transfer or validation to new CMO partners
• Support regulatory submissions and post-approval variationsHR_T_001_Job Ad_MSAT Senior Quality Control Project Lead
• Act as a technical liaison and internal consultant on QC-related matters, providing guidance to MSAT,
Regulatory, Project, and Management teams, while contributing additional awareness of project-
related aspects
• When necessary, ensure on-site presence at CMOs for analytical clarifications and troubleshooting,
with a willingness to travel as required (approximately 5-10%)
Your profile
• 10+ years of experience in pharmaceutical QC/analytical roles, including at least 5 years in matrix,
project-driven environments, with direct involvement in analytical method transfer and validation
• Strong expertise in small molecule analytical control, experience with biologics is a plus
• Hands-on experience with HPLC/UHPLC, including method validation, troubleshooting, and
development of stability-indicating methods
• Proven experience working with CMOs in an outsourced model
• Solid knowledge of relevant guidelines and regulations, including:
o ICH Q1, Q2, Q3A/B/C/D, Q6
o ICH Q9, Q10
o EU GMPs
• Experience with sterile products is highly desirable
• Strong scientific rigor and sound analytical judgment
• Project-oriented mindset with the ability to operate in cross-functional teams
• Ability to assess technical decisions considering business and regulatory impact
• Proactive, solution-driven approach
• Strong collaboration and communication skills
• Comfortable working in a lean, evolving organization
• The company’s working language is English; full professional proficiency in English is required for this
role.
• MSc or PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline, or
equivalent through relevant professional experience
We offer
• A unique opportunity to work daily with highly experienced individuals and teams in a fast-
deciding company
• Being in a determinant position to advance strategic company interests
• A full-time position
• Competitive remuneration according to your competencies and commitment
• A dynamic and modern work environment aimed at promoting work-life balance
Ready to take on a new challenge? Then please submit your application via LinkedIn or email it to
We look forward to meeting you soon!
Please note that we will only contact
shortlisted candidates.
Regulatory Affairs CMC Manager
As a Regulatory Affairs CMC Manager, you will contribute to the filing of technical, medical-scientific,
and administrative changes, as well as renewals and new registrations to health authorities worldwide
(EU/CH, Africa, MENA, SE-Asia, AU/NZ).
Key Responsibilities
• Serve as the primary Regulatory Affairs CMC contact for the company’s product portfolio.
• Support all CMC activities throughout the application and post-submission phases of assigned
projects/products.
• Contribute to review and provision of regulatory advice for proposed CMC changes.
• Author and/or critically review CMC sections of regulatory submissions for APIs, DP technical
transfers & other post-approval variations including responses to health authority questions.
• Liaise with internal and external parties to author regulatory documents.
• Interpret and apply global/regional regulatory guidelines and regulations.
• Ensure full compliance with regulatory requirements.
• Keep abreast of applicable current regulatory environment: communicate guidelines,
requirements and regulatory documents of interest.
• Lead assigned regulatory projects and develop strategies.
• Own and maintain Module 3 content in cooperation with Quality, MSAT, and external
manufacturers.
• Lead RA assessment of manufacturing, specification, analytical, and supplier changes.
• Work in a matrix environment and collaborate closely with MSAT, Quality & Supply Chain
departments as well as external service providers.
Your Profile
• University degree in Science (e.g., Pharmacy, Chemistry, or Biology – minimum MSc or
equivalent degree).
• Minimum of 5 years of experience in regulatory affairs and a proven history in compiling
complex CMC documentation for small molecules & biologics (drug substance & drug product).
• Ability to develop and prepare successful CMC strategies for variations, renewals, or new
registrations (new MAAs).HR_T_001_Job Ad Regulatory Affairs CMC Manager 2026
• First experience in interacting directly with European Health Authorities, national and EMA (e.g.
discussing timelines for response packages, clarification of variation categories etc.).
• Critical understanding of the regulatory landscape within the EU and CH (additional regions is a
plus).
• Experience acting as Regulatory Product Lead for one or more products is a strong asset.
• Prior exposure to externally manufactured products and CMOs is highly desirable. Excellent
communication and organization skills.
• Fluent in English - good command of German or French is desirable.
• Very good knowledge of MS Office applications.
We Offer
• A unique opportunity to work daily with highly experienced individuals/teams in a fast-deciding
company.
• Being in a determinant position to advance strategic company interests.
• A full-time position.
• Competitive remuneration according to your competencies and commitment.
• A dynamic and modern work environment aimed at promoting work-life balance.
Ready to take on a new challenge? Then please send your application to jobs@eumedica.ch.
We look forward to meeting you soon!
Please note that we will only contact short-listed candidates.
Any personal data you provide will be processed solely to manage your application within the recruitment
process.