Regulatory Affairs Specialists
Have you ever heard news about government agencies seizing goods unfit for human use, and arresting the manufacturers behind them? Have you ever thought about how we make sure the food we eat or the medicine we take is actually safe? You should know that in every country in the world, there are government bodies that oversee the manufacturing of products related to public health. These bodies also set standards and regulations that define the procedures that must be followed when manufacturing any food or health product - and it's these standards that guarantee the safety of those products. Governments have given these standards and regulations the name "regulatory affairs." That's why food factories and pharmaceutical companies hire employees known as "regulatory affairs specialists" - people who know these standards and regulations inside out, and who are responsible for obtaining government licenses for the products their companies make. Regulatory affairs specialists can also work within the government agencies that oversee manufacturing, where their job becomes making sure companies comply with the safety standards and regulations for food, medicine, cosmetics, medical equipment, and other products related to people's health.
Meet the Writer: Waleed Abo Omiraa
What You'll Actually Do
The core tasks and responsibilities that fill a typical day.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Compile and maintain regulatory documentation databases or systems.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Develop or conduct employee regulatory training.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Participate in internal or external audits.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Write or update standard operating procedures, work instructions, or policies.
- Coordinate recall or market withdrawal activities as necessary.
- Develop or track quality metrics.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Identify relevant guidance documents, international standards, or consensus standards.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Recommend adjudication of product complaints.