We are looking for Freelance Local Regulatory Affairs Specialists for a long-term partnership across EU and non-EU counties.
Main Responsibilities
• Act as the local Regulatory Affairs representative; communicate with regulatory authorities regarding pre-submission strategies, regulatory pathways, compliance requirements, and submission follow-ups.
• Serve as the primary contact and subject matter expert for regulatory affairs, advising internal teams and external clients on local regulatory requirements.
• Support the preparation and submission of regulatory applications, including new marketing authorisation (MA) applications, variations, renewals, MA transfers, and related correspondence. Submit national declarations and notifications as required.
• Compile and maintain regulatory documentation and databases, track life-cycle submissions, and oversee regulatory duties for the assigned product portfolio.
• Translate and revise product information (e.g., Summary of Product Characteristics, Package Leaflet).
• Validate artworks to ensure compliance with the marketing authorisation and local legislation.
• Review promotional materials for regulatory compliance.
• Advice on launch requirements.
• Support with orphan medicines.
• Work within clients’ systems.
Requirements:
• University degree in medicine, pharmacy, life sciences, or a related field.
• Experience regulatory affairs working with pharmaceuticals (minimum 2 years)
• Professional proficiency in English, both spoken and written.
• Strong knowledge of local regulations and requirements.
• Attention to detail
• Focused on quality and productivity
• Customer-oriented
Why join us
• Engaging, dynamic and diverse work in a young and rapidly growing company.
• International and multicultural environment.
• A workplace where your input matters and has an impact.
• Broad opportunities for self-expression and professional growth.
• Remote work
Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.