Product Regulatory Compliance Specialist
Dexian, Westbrook, ME, United States
Job Title
Product Regulatory Compliance Specialist (Hybrid)
Pay Rate $27 - $28.57 hourly on W2
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)
Focus on accuracy: data review and processing, reporting & declarations for multiple countries, schemes and time periods
Organized: generating and organizing large number of files and documentation
Nice to have Skillsets
Experience with some company ERP systems (e.g., 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 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.
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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Pay Rate $27 - $28.57 hourly on W2
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)
Focus on accuracy: data review and processing, reporting & declarations for multiple countries, schemes and time periods
Organized: generating and organizing large number of files and documentation
Nice to have Skillsets
Experience with some company ERP systems (e.g., 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 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.
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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