CMC Writer International

Responsibilities:

• Preparation of Drug-Device Combination dossier to be submitted in the targeted markets for Infection Prevention Portfolio.
• Ensure the regulatory compliance to Directive 2001/83/EC, MDR regulation and Drug-device combination products guideline.
• Liaise with multidisciplinary teams to collect, review and compile technical data.
• Maintain and protect existing licenses in international, ensuring compliance with local regulations.
• Review change control / design control documentation to ensure regulatory compliance.
• Ensure that the pharmaceutical products sold in international meet the local regulatory requirements and support the local registration of these products in a professional, compliant and timely manner.
• Report to his direct manager.

Profile:

• Pharmacist, Biomedical or Mechanical Engineer degree
• Minimum of 3 years of experience in medical device regulatory and technical file writing, an additional experience in CMC of medicinal products would be a plus.
• Knowledge of drug-device combination pharmaceutical requirements.
• Experience interfacing with multifunctional and multicultural groups, including international regulatory agencies.
• Must be detail oriented with excellent organizational skills with the ability to analyse regulatory documents (e.g. registration files)
• Ability to read professional journals, technical procedures or governmental regulations. Ability to write reports, registration modules and procedure manuals.
• Other skills and abilities: Excellent verbal and written communications skills, strong negotiation and facilitation skills. Structured and largely self-organized. Strong planning, time management and prioritization skills with the ability to multitask. Strong computer skills including the office pack processing is required
• Excellent English language skills required. Any other EU language is a plus.