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The Specialist 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 companiescompliance 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 of 4 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 :
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