• Drive compliant regulatory submissions in a fast‑paced global environment.
• Ensure cross‑functional alignment to accelerate regulatory deliverables.

¿Dónde vas a trabajar?

Our client is a Global biopharmaceutical multinational, leader in industry.

Descripción

• Review promotional and non-promotional materials in accordance with the Company internal promotional guidelines, national regulations and Codes of Practice. Provision of guidance and assistance to Marketing during preparation of promotional material.
• Cross functional interactions with Business Unit, Medical and other departments if required. Provision of regulatory advice, as applicable.
• Translation of Regulatory documents. Submission and follow-up of regulatory submissions to national authorities, as well as the variations to product information in centralized procedures,acting as a Liaison with Int RA for those activities, as required.
• Revision of regulatory documents: outer cartons, labels and leaflets of Firm's marketed products and clinical trials.
• Review of tender documentation and regulatory dossiers, as required.
• Submission of clinical trials amendments and notifications to competent authorities of the clinical trials under his/her responsibility, as applicable.
• Regulatory Intelligence: Competitors, new regulations or other relevant information.
• Quality topics: Knowledge of applicable regulations, preparation and update of Quality SOPs, management of complaints and other quality topics.
• Creation and update of SOPs and associated process documentation as required.

¿A quién buscamos (H/M/D)?

A successful Regulatory Affairs Consultant should have:

• University degree in Health Sciences (e.g. Pharmacy or similar).

• A Master's degree in Regulatory Affairs or equivalent is considered a plus.

• 5+ years of experience in Regulatory Affairs, preferably in an affiliate environment.

• Experience in the review of promotional and non‑promotional materials, in accordance with applicable regulations and Codes of Practice.

• Knowledge of regulatory procedures, including registration and maintenance activities.

• Experience working in direct contact with Health Authorities is considered a plus.

¿Cuáles son tus beneficios?

• 9‑months temporary contract.
• Opportunity to join a top-tier American biopharma multinational.
• Competitive salary: €70.000 - €80,000 gross/year, depending on experience.
• Hybrid working model and international exposure.
• Immediate start