Introduction:
The regulatory affairs associate is in charge of enforcing workplace rules and complying with federal regulations in all aspects of the business. They are familiar with all of the laws that relate to the business in which they operate and ensure that they are obeyed. A regulatory associate’s major responsibility is to examine the processes utilized in their sector and provide rules for the specific assignment. They should be familiar with regulatory requirements, ensuring that all employees are familiar with the legal requirements that apply to their jobs. Coordination with other divisions to gather data, performing inspections and audits, critically evaluating procedures, interacting with external authorities, developing standards and guidelines for each process, and producing daily updates are all part of the job description. They will work with the government affairs and may be required to submit papers as the step of the procedure.
Regulatory Affair Associate Job Titles:
- Regulatory Affair Associate
- Regulatory Affair Assistant
Regulatory Affair Associate Job Summary:
We need a regulatory affairs associate with a bachelor’s degree in biochemistry, health science, or biomedical science. The candidate oversees submission projects ranging from simple to somewhat complex, involving numerous cross-functional regulated filing teams. The associate sets and manages proposal organizers and associated deadlines, coordinates tactical filing group meetings, and promotes submission operations on international regulatory project teams for allocated goods, with feedback from submission groups and their managers. Participates in the development of construction plans using formed layouts, proposals and makes deals to publish timeframes with workgroups, helps manage various projects and competing demands, serves as the main submission activities interaction with working groups, offering direction and interaction of defined submission processes and systems, plans and leads submission staff meetings, identifies impediments, and collaborates with the management to build team solutions. Demonstrates leadership qualities in a submitting team and the ability to impact without direct control. Internally and externally, creates and maintains healthy relationships.
Regulatory Affair Associate Job Responsibilities and Duties:
- Ensure that a company’s business conforms with the requirements of the location in which it wishes to sell it
- Stay current on national laws, regulations, and client habits.
- Create and write coherent justifications and reasons for new product licenses
- Meet stringent deadlines for license variants and renewals
- Hold information in a database or system
- Ensure regulatory compliance
- Counsel others on compliance-related issues
- Give a technical assessment of facts or studies
- Organize legal documentation operations
- Arrange and conduct product tests and evaluate trial data
- Use the computer applications and resources provided by the specialist
Regulatory Associate Skills and Qualification:
- A bachelor’s degree in biochemistry, health science, or biomedical science is required
- Minimum of three years of experience in a related field.
- An understanding of both lawful and scientific aspects is required, as well as the ability to handle new ideas quickly.
- Analysis method and problem-solving skills are required.
- Confidence in reporting to managers
- Professionalism and tact
- Integrity and professional approach to work
- Punctual, reliable and must have strong communication skill
- Strong verbal and oral communication skills
- Attention to detail, prioritization skills, and time management
- Motivational and communication skill
