Regulatory Affairs Associate
- - Responsible for preparing regulatory submissions which require some interactions with other members in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity.
- Responsible for development and acquisition of required regulatory skills and knowledge, with manager support.
- May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department
- Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
- Seeks assistance from appropriate internal and external resources.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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