Product Regulatory Compliance Specialist

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)
- 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 (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 review 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 stands at the forefront of Talent Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

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.