Job Description of Regulatory Compliance Specialist
A compliance specialist ensures that a company's operations adhere to the laws regulating the particular industry. The type of industry determines specific responsibilities, and the fields that use a compliance specialist vary greatly.
General Job Duties Regulatory Compliance Specialist
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies. Keeps abreast of changes in regulations, including attending regulatory conferences and seminars.
Provides product information to internal and external customers with respect to domestic and foreign regulatory requirements in the area of FDA regulations and related laws.
Responds to written, electronic and verbal technical requests and client inquiries involving general product regulatory information requests.
Duties and Responsibilities for Regulatory Compliance Specialist
- Assist Compliance Supervisor and Quality Assurance Director in leading the ongoing development, implementation and verification of Quality Systems
- Manage quality and regulatory compliance with Health Canada regulations, FDA 21 CFR US regulations and customer requirements for Drug Products, Natural Health Products and Cosmetic Products
- Handle Health Canada regulatory audits and customer quality audits in conjunction with Quality Assurance Manager
- Execute Internal GMP and housekeeping audits
- Follow up on audits observations and implementation of corrective and preventative actions
- Ensure the maintenance of facility licenses and cosmetic drug listings on regular basis
- Write and execute IQ/OQ protocols for manufacturing equipment and filling equipment for drug products
- Write and execute Process Validation Protocols for manufacturing, filling and packaging processes for drug products, also for cosmetics where required by external customers
- Coordinate the preparation of validation reports
- Monitor and track Quality System deviation and facilitate the execution of Corrective Actions / Preventive Action (CAPA)
- Facilitate investigation on OOS (Out of Specification) results and initiate & follow up on CAPA
Initiate, review and approve change control
- Perform other related assignments and duties as required and assigned
- Develop subordinates in their role
- Bachelor Degree of Science preferred in Chemistry or equivalent
- At least 3 years of Regulatory Compliance/Technical Writing experience in a regulated industry
- Thorough knowledge of GMPs/GLPs and regulatory requirements is essential
- Proven organizational skills and attention to details
- Extensive working knowledge and experience with a document control system
- Computer skills in spreadsheets, word processing and databases desired
- Must be able to work independently and interact effectively with others from a variety of positions and backgrounds
- Ability to effectively multi-task and deal with changing priorities, problem solving
- Experience with root cause analysis, corrective action plans preferred