Product Regulatory Compliance Specialist

Title: Product Regulatory Compliance Specialist

Location: Westbrook, ME (Hybrid)

Duration: Long Term Contract

Required:

• 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

• Experience with some company ERP systems (eg, SAP)

• Experience generating standard reports out of systems

Duties

• 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.

TGIT01

Job Type: Contract

Pay: $25.00 - $28.00 per hour

Work Location: Remote