Regulatory Affairs Team Lead – Generics
TRIGA Consulting GmbH & Co. KG
full-time
Posted on:
Location Type: Remote
Location: Germany
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Job Level
About the role
- Lead and build the Regulatory Affairs team; initially responsible for one Regulatory Affairs employee
- Develop and implement regulatory strategies to ensure compliance with national and international regulations (e.g., EMA, BfArM, etc.)
- Prepare, review, and submit regulatory documentation such as product dossiers, marketing authorization applications, variations, and renewals to the competent authorities
- Serve as the primary point of contact for national and international regulatory authorities
- Respond to authority queries, organize and attend meetings, and ensure timely feedback and communication
- Provide regulatory advice during product development
- Ensure that new products meet all relevant regulatory requirements
- Review and ensure regulatory compliance of product labeling, promotional and advertising materials, and clinical documentation
- Monitor post-marketing regulatory obligations, including adverse event reporting and product recalls
- Monitor regulatory changes and standards and communicate relevant updates to internal stakeholders
- Collaborate closely with Quality Assurance, Research & Development, Manufacturing, and other departments
Requirements
- Degree in a scientific or pharmaceutical discipline
- At least 5 years of professional experience in Regulatory Affairs within the pharmaceutical industry, ideally in generics
- Experience with EU marketing authorization procedures for medicinal products
- Strong understanding of global regulatory frameworks, in particular EMA, FDA, and ISO
- Excellent written and verbal communication skills
- Analytical mindset and strong problem-solving skills
- Structured, detail-oriented working style and ability to manage multiple projects in parallel
- Proficient in regulatory submission tools and related software systems
- Fluent German and English
Benefits
- Inclusive work environment with development opportunities
- Attractive salary and benefits package
- Highly flexible arrangements with a 100% remote working option (with occasional/rare travel)
- Opportunity to work on international, innovative projects with global reach
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory documentationmarketing authorization applicationsproduct dossiersregulatory complianceadverse event reportingproduct recallsEU marketing authorization proceduresglobal regulatory frameworksISO
Soft Skills
communication skillsanalytical mindsetproblem-solving skillsdetail-orientedproject managementcollaborationleadership