Job Description

The Associate Regulatory Affairs CMC (RA-CMC) is responsible for and contributes to driving assigned CMC regulatory activities including planning CMC Dossier generation for assigned submissions worldwide. Role is responsible for ensuring companies compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics. IMPACT: Impacts the results of own team or even influences a range of customer, operational, project or service activities of closely related teams with own contributions. Explains complex or even difficult/sensitive information to others in straightforward situations and interacts across business areas. May even advance discussions and build consensus across the business and with external parties regarding own technical area. COMPLEXITY: Performs a range of routine or even non-routine assignments to solve problems of low to moderate complexity that require working knowledge and experience in own job discipline. Analyzes factual information and possible solutions to make independent judgement, recommendations and decisions. May also use best practices to improve products or services. ACCOUNTABILITY/ INDEPENDENCE: Accountable for the quality of own work. Works independently and receives a moderate to low level of guidance and direction within clear or even broad guidelines. EXPERIENCE: Requires a graduate background plus some to substantial relevant professional experience, and good knowledge and experience in own discipline and beyond. Minimum 1 -3 years of pharmaceutical industry experience Education: Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline) Job Specific Competencies & Skills: Ability to understand and support the development of regulatory CMC strategies and CMC dossiers i.e. Module 3, Module 2 Comprehensive knowledge and Experience with developing regulatory CMC strategies and CMC dossier content requirements i.e. Module 3, Module 2. Experience in preparation and management of regulatory CMC documentation, including preferably international new product applications or variations Experience with regulatory CMC life-cycle management activities would be an asset Practical experience in one of the following area synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management Awareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries. Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German). Good interpersonal skills and flexible mindset. Attention to details. Ability to work in multinational teams.

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