Product Regulatory Compliance Specialist job in Westbrook
Westbrook CorTech LLC
| Job Ref: | 372725 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 28.57/Per Hour |
| Remote: | No |
Location |
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| City: | Westbrook |
| Post Code: | 04092 |
| Map: |
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Description |
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JobsRUs.com is seeking to hire a Product Regulatory Compliance Specialist for our client in Westbrook! Benefits Available! Weekly Pay! $28.57/Hour M-F 7 AM to 3 PM Main tasks: EPR reporting: - Working on specific EPR application to load raw data, trigger calculation, and reporting files. -Review files for data accuracy. -Transferring EPR data onto the reporting portal at the required frequency SAP: - Generate standard reports for EPR calculations - Run material master reports to collect product specifications Excel: - Work with complex files using formulas and pivot tables - Integrate data from multiple sources to generate combined views & reports In This Role You Will: ? Coordinate regulatory documents, ensure that submissions are timely and regulatory objectives are met. ? Research scientific and regulatory information in order to write, edit, and review reports. ? Compile all materials required for submissions, license renewals, and annual registrations. ? Keep informed of professional and global regulatory information. ? Work with governmental regulatory agencies. ? Perform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. ? Compile all materials required in submissions, license renewal and annual registrations. ? Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. ? Monitor and improve tracking/control systems. ? Keep abreast of regulatory procedures and changes. ? Potentially direct interaction with regulatory agencies on defined matters. ? Recommend strategies for earliest possible approvals of clinical trials applications. What You Need to Succeed: ? Self-starter, with ability to work independently, initiates and coordinate projects and meet deadlines within a changing, fast-paced environment. ? Excellent problem-solving skills, sound judgment and strong interpersonal, presentation and communication skills. ? Pays close attention to detail, handles confidential information with discretion and possesses a can-do attitude. ? Strategic-thinker, goal- and team-orientated, able to handle difficult issues in a professional, assertive and proactive manner and history of developing cross-functional relationships with all levels of an organization. ? Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk. ? Facilitates and participates in process improvements across teams and organizations. ? You meet the physical requirements that go with working as a Regulatory Specialist ? Extensive sitting, phone and computer use. | |
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