Specialist, Labelling & Compliance Regulatory Affairs (Biotech)

TL;DR

Specialist, Labelling & Compliance Regulatory Affairs (Biotech): Managing labelling and compliance activities for rare disease treatments with an accent on RIMS reporting and regulatory documentation. Focus on maintaining accurate regulatory records, conducting gap analyses for local labels, and ensuring compliance with international jurisdictions.

Location: Hybrid (Must be based in Parma, Italy)

Salary: Minimum €39,760

Company

An international research-focused biopharmaceutical group with 90 years of experience in developing and marketing innovative drugs across various therapeutic areas.

What you will do

• Contribute to accurate RIMS reporting for the Global Rare Diseases portfolio and train colleagues on its consistent use.
• Track and monitor the fulfillment of regulatory obligations and design quality checks for RIMS data.
• Extract RIMS data to calculate and report key performance indicators (KPIs).
• Support inspection preparation and coordinate SOP training to ensure compliance.
• Maintain company core data sheets and local labelling, performing gap analyses between local labels and the CCDS.
• Legalize documents for international submissions and ensure all work meets safety and regulatory requirements.

Requirements

• Degree in life sciences (Pharmacology, Biology, Chemistry, Pharmacy, Medicine) or an IT system field.
• Experience in Regulatory Affairs, preferably with exposure to international jurisdictions.
• Proficiency in RIMS, document management systems (eDMS), and MS Office/Adobe Acrobat.
• Familiarity with eCTD structure and the drug development regulatory life cycle.
• Excellent English written and oral communication skills.
• Ability to work from the HQ in Parma, Italy (Hybrid).

Culture & Benefits

• Comprehensive healthcare programs and private medical insurance.
• Pension and flexible benefits programme.
• Wellbeing initiatives and work-life balance support.
• Robust relocation support for eligible candidates.
• Flexible working arrangements and tax assistance services for foreign colleagues.