Regulatory Affairs Lead (mfd)
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
unisite ag is a service provider in the field of Employer Branding & Talent Management. We provide consulting services to clients in the chemistry pharmaceutical biotech medical device and life sciences industries.
Our client is a well-established Swiss company with a strong track record as an innovative and reliable partner within the life sciences sector.
On behalf of our client we are currently looking for a:
Regulatory Affairs Lead (m/f/d)
Location: Basel Metropolitan Area
Position
In this role you will take a key position in the further development and strategic strengthening of the Regulatory Affairs function. You will combine hands-on regulatory work with strategic oversight and ensure that regulatory requirements across multiple product categories are managed efficiently and proactively.
Working closely with internal stakeholders external partners and international health authorities you will contribute significantly to maintaining regulatory compliance while supporting the companys product development and global business activities.
Tasks
- Development and continuous improvement of the global Regulatory Affairs strategy with a focus on pharmaceutical APIs
- Regulatory oversight of relevant dossiers and documentation including Drug Master Files (DMFs) ASMFs CEPs and technical documentation
- Interaction with health authorities and coordination of regulatory responses and submissions
- Responsibility for labeling governance and regulatory claims across different product categories
- Providing regulatory input for new product development projects and product lifecycle management
- Selection coordination and management of external regulatory consultants
- Contribution to the development and improvement of internal regulatory processes standards and training programs
- Ensuring regulatory alignment across requirements related to Pharma IVD and related life science product areas
- Performing or coordinating regulatory risk assessments for different product categories
- Monitoring global regulatory developments and contributing to proactive regulatory intelligence
- Leading or supporting cross-functional regulatory projects and initiatives
Qualification
- Degree in Life Sciences Chemistry Biochemistry Pharmacy or a comparable scientific discipline
- 10 years of experience in Regulatory Affairs within a regulated international environment
- Strong regulatory background in the pharmaceutical sector; experience in diagnostics / IVD or related product categories is an advantage
- Experience interacting with international regulatory authorities and managing regulatory documentation and submissions
- Ability to combine strategic thinking with hands-on operational regulatory work
- Pragmatic and structured working style with strong problem-solving capabilities
- Business-oriented mindset and ability to collaborate with cross-functional stakeholders
- Experience managing external partners or consultants is an advantage
- Fluency in English is required; German proficiency at a minimum of B1 level is expected
- Experience with Chinese regulatory frameworks would be considered a strong advantage
Seize this opportunity to shape your future - we look forward to receiving your application!
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Die unisite ag ist ein Beratungsunternehmen und Dienstleister im Bereich Talent Management. Wir beraten Kunden aus den Bereichen Chemie, Pharma, Biotech, Medical Device & Life Sciences.
