Freelance Local Regulatory Affairs Specialist

Freelance Local Regulatory Affairs Specialist

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.

Contact us