Regulatory Affairs Specialist CMC

Mission

Provide regulatory advice and prepare and maintain the chemical-pharmaceutical regulatory documentation for strategic brands for international and local products, maximising compliance with current guidelines while minimising regulatory commitments.

Tasks and Responsibilities

Participate in different projects (Pharma and Chemistry) developed by the company. Coordinate the preparation of chemical-pharmaceutical documentation required for the presentation of Variations and Renewals of products sold by the company, as well as the modifications to be made to the active substance. Define the strategy, and manage and coordinate the resolution of issues related to new variations of authorised products. Contact and coordinate with the different IF Manufacturing, Quality Assurance and Quality Control departments (SAB), Reinbek and Ranke Química in order to obtain the information required for preparation of the chemical-pharmaceutical documents (CMC). Evaluate and manage/respond to questions regarding chemical-pharmaceutical issues from the Industrial Area and R&D. Supervise the scientific style, content and coherence of the chemical-pharmaceutical portion of the final dossier in order to minimise the commitments acquired with the authorities and, in turn, variations in the chemical-pharmaceutical portion of the dossier.

Education & specific knowledge

• University Degree in Life Sciences (preferably Biochemistry, Biotechnological or Pharmacy...)
• International regulatory affairs legislation in CMC topics and procedures for biologics products in both EU and non-EU Regulatory Agencies.
• Pharmaceutical development, Analysis, Production and Quality Control of biologic products , from development to post-marketing phases.
• High level of English.
• Team player with ability to communicate effectively across several scientific disciplines.

Experience

2 - 3 years of experience in a similar position in a Regulatory Affairs Department.

Values

• Care
• Courage
• Innovation
• Simplicity

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