Regulatory Affairs Consultant
Regulatory Affairs Consultant (API Registration)
Location: Remote
Contract Length: 6 Months
Start Date: January 2027
Language Requirement: Fluent German and English
Overview
Our client is seeking an experienced Regulatory Affairs Consultant to support regulatory activities related to Active Pharmaceutical Ingredients (APIs). This contract opportunity will focus on API registrations, lifecycle management, and ensuring regulatory compliance across relevant markets.
Key Responsibilities
- Prepare, review, and maintain regulatory documentation for API registrations.
- Support regulatory submissions and variations for active pharmaceutical ingredients.
- Manage post-approval activities and product lifecycle maintenance.
- Ensure compliance with applicable regulatory requirements and guidelines.
- Assess the regulatory impact of product and process changes.
- Coordinate and prepare variation submissions and regulatory updates.
- Collaborate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, and external stakeholders.
- Provide regulatory expertise and guidance on API-related projects.
Required Experience
- Proven experience within Regulatory Affairs in the pharmaceutical industry.
- Strong hands-on experience with API registration activities.
- Demonstrated experience in lifecycle management and post-approval regulatory activities.
- Good understanding of EU regulatory requirements and submission processes.
- Ability to work independently and effectively within a consultancy environment.
- Fluent German and English language skills, both written and spoken.
Contract Details
- 6-month contract
- Start date: January 2027
- Remote working arrangement
- Opportunity to work with a leading pharmaceutical organisation
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