Job Title: Product Regulatory Compliance Specialist/Compliance Specialist

Location: Westbrook, Maine (Hybrid)

Duration: 12 Months 

Pay Range: $25/hr  - $29/hr

**About the Role**

We are seeking an experienced Regulatory Specialist to join our team in a hybrid capacity. This role requires a local candidate who can work from 7am to 3pm. The ideal candidate will have 4 to 6 years of experience and will be responsible for coordinating regulatory documents, ensuring timely submissions, and meeting regulatory objectives.

**Responsibilities**

• Coordinate and prepare document packages for regulatory submissions for both new and mature products.
• Ensure alignment and compliance with local and regional registration requirements, as well as company policies.
• Research scientific and regulatory information to write, edit, and review reports.
• Compile materials required for submissions, license renewals, and annual registrations.
• Work with governmental regulatory agencies and potentially interact with them on defined matters.
• Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitor and improve tracking/control systems and keep informed of regulatory procedures and changes.
• Recommend strategies for the earliest possible approvals of clinical trials applications.

**Education Qualification**

• A relevant degree in a related field is preferred.

**Required Skills**

• Good analytical skills and the ability to learn systems quickly.
• Intermediate Excel skills, including the ability to use formulas and create pivot tables.
• Strong focus on accuracy in data review and processing, reporting, and declarations for multiple countries, schemes, and time periods.
• Highly organized with the ability to generate and organize a large number of files and documentation.
• Experience with ERP systems (e.g., SAP) and generating standard reports is a plus.
• Self-starter with excellent problem-solving skills, sound judgment, and strong interpersonal, presentation, and communication skills.
• Strategic thinker with a goal- and team-oriented approach.
• Ability to handle difficult issues in a professional, assertive, and proactive manner.
• Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk.
• Ability to facilitate and participate in process improvements across teams and organizations.
• Must meet the physical requirements of extensive sitting, phone, and computer use.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.