Product Regulatory Compliance Specialist
Dexian, Nashville, TN, United States
Job Title: Product Regulatory Compliance Specialist (Hybrid)
Duration: 12 months (possible extension)
Location: Westbrook Maine 04092
Pay Rate: $27 - $28.57 hourly on W2
Job Summary: Work Schedule: 7am - 3pm ET – Experience Level: Intermediate (4 to 6 years)
Top (3) Required Skillsets
Good analytical skills
Ability to learn systems
Intermediate Excel skills (ability to use formulas and create pivot tables)
Additional Skillsets
Experience with some company ERP systems (eg, SAP)
Experience generating standard reports out of systems
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 reporting portal at 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 and internal audits and inspections
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, initiate 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
Meets the physical requirements that go with working as a Regulatory Specialist – extensive sitting, phone and computer use
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
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Location: Westbrook Maine 04092
Pay Rate: $27 - $28.57 hourly on W2
Job Summary: Work Schedule: 7am - 3pm ET – Experience Level: Intermediate (4 to 6 years)
Top (3) Required Skillsets
Good analytical skills
Ability to learn systems
Intermediate Excel skills (ability to use formulas and create pivot tables)
Additional Skillsets
Experience with some company ERP systems (eg, SAP)
Experience generating standard reports out of systems
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 reporting portal at 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 and internal audits and inspections
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, initiate 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
Meets the physical requirements that go with working as a Regulatory Specialist – extensive sitting, phone and computer use
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
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