Specialist in Regulatory Compliance supporting sustainability initiatives at FERI Group. Responsible for analysis, reporting, and development of sustainable finance products.
TK
Hybrid Regulatory Affairs Manager – Generics
Posted last month
About the role
- Regulatory Affairs Manager managing drug approval processes for a successful pharmaceutical company. Responsible for documentation submission and lifecycle management in compliance with regulations.
Responsibilities
- Independently manage procedures for medicinal product approvals
- Prepare regulatory submission documentation in eCTD format and submit to authorities
- Life-cycle management (renewals, variations)
- Direct contact with regulatory authorities and point of contact for internal and external RA queries
- Maintain and optimize the regulatory information database
- Prepare and review product information texts
Requirements
- A completed degree (e.g., pharmaceutical or natural sciences)
- Professional experience in Regulatory Affairs
- Excellent German and English language skills
- Analytical thinking, quick comprehension, and strong organizational skills
- Team player with strong communication skills
Benefits
- Flexible working arrangements (including remote work)
- 30 days annual leave + 3 bridge days
- A friendly team
- Attractive salary & comprehensive social benefits (including pension and health coverage…)
- Excellent training and development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Graduate role in Internal Audit & GRC services at PwC, supporting organisations in regulatory compliance and risk management. Assisting with data analysis, process mapping, and client engagements.
Export Control / Trade Compliance Officer ensuring customs compliance with Australian and U.S. laws. Advising on trade compliance issues and solutions across various projects and teams.
Vice President of Compliance & Regulatory Affairs leading compliance strategy for Cotulla Education. Supporting growth and regulatory compliance across multiple institutions and campuses.
Compliance Officer with focus on AML and compliance tasks at Schulz & Cie. Consulting. Conducting audits, transaction monitoring, and managing regulatory issues in financial services.
Lead compliance and risk management at Thndr Securities Brokerage, ensuring regulatory adherence and overseeing compliance operations. Collaborate with teams to mitigate risks and educate on compliance programs.
Key contributor in Integrated Resource Planning at Duke Energy. Prepare executives for regulatory testimonies on future energy demands and regulatory compliance.
CMC Regulatory professional managing regulatory compliance activities for veterinary biological products at Zoetis. Supporting development and inspections for the new GMS Atlanta site with FDA and USDA expectations.
Compliance Associate supporting Fidelity's Asset Management Compliance operations through various responsibilities in financial services. Engaging in problem - solving and maintaining organizational compliance while collaborating with multiple departments.
CMC Regulatory professional at Zoetis preparing regulatory documentation and ensuring compliance with FDA and USDA regulations. Managing facility documents and participating in cross - functional project improvements.