Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Hamburg, Hamburg - Adecco
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Regulatory Affairs Director
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
vor 2 Monaten
Job Summary
Adecco is seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.
Key Responsibilities
- Support the preparation of regulatory documents in eCTD format
- Collaborate with cross-functional teams to ensure compliance with national and international regulatory procedures
- Develop and maintain regulatory dossiers and ensure their accuracy and completeness
- Assist in the creation of product information texts and electronic submission forms for EU and US procedures
- Support the extension, renewal, and update of regulatory approvals and the archiving of regulatory documents using eCTD Manager
- Perform other quality management tasks as required
Requirements
- Completed technical or natural science education and initial work experience
- Familiarity with current legislative and regulatory requirements in the pharmaceutical industry
- Proficient in MS Office applications and experience with database systems such as eCTD Manager
- High level of commitment, flexibility, reliability, and teamwork
- Fluent German and English language skills in writing and speaking
Benefits
- Opportunity to work in a dynamic and established family-owned company
- Flexible working hours with core working hours and mobile work options
- Additional benefits such as bike leasing, travel expense reimbursement, and company pension scheme
- Adecco will support you throughout the entire recruitment process