Senior Regulatory Specialist
Senior Regulatory Specialist
Posted on :
04-06-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Hybrid
What You will do -
- Identifies information sources and resources for local regional and global regulations
- Collects organizes and maintains files on local regional and global regulatory intelligence and other related information
- Monitors the regulatory environment (specific regulations guidance and other relevant information by product types geography etc.)
- Provides information used to evaluate proposed products for regulatory classification and jurisdiction
- Researches requirements (local national international) applicable guidance and standards and options for regulatory submissions approval pathways and compliance activities
- Assists in the development of regulatory procedures and SOPs
- Collects and organizes information on requirements for regulatory quality preclinical and clinical data to meet applicable regulations
- Organizes materials from preclinical and clinical studies for review and assists in the review process
- Compiles and organizes materials for pre-submission reports and communications
- Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies
- Tracks the status of applications under regulatory review and provides updates to the regulatory team
- Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
- Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings
What you will need-
Education / Work Experience:
- BS in Engineering Science or related degree; or MS in Regulatory Science
- 4 yrs experience
Knowledge / Competencies:
- Time management skills writing coordination and execution of basic regulatory items
- Clearly conveys information to peers supervisors and other stakeholders
- Assists in the preparation for meetings with regulatory agencies and other stakeholders; in the preparation of briefings and other information documents
- Communicates information on regulatory requirements to other departments and business units
- Composes routine communications with regulators and other key stakeholders
- Creates clarity and direction amid complexity and develops solutions for self colleagues and the organization
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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