Regulatory Affairs Specialist Job Description

A regulatory affairs specialist, also known as a regulatory affairs manager, is a public health professional whose duties involve managing the regulatory affairs function of an organization.

Regulatory affairs specialists work in a wide variety of industries, including health care, pharmaceuticals, biotechnology, medical devices, and cosmetics.

Regulatory affairs specialists are responsible for assisting an organization in the development, submission, and approval of its product to the Federal Drug Administration (FDA) and other regulatory bodies.

Regulatory affairs specialists have extensive knowledge of product promotion, as well as applicable legislation, and are responsible for ensuring that an organization’s products comply with FDA regulations.

Job Brief:

We’re looking for Regulatory Affairs Specialist to lead the charge in ensuring our company is compliant with all applicable regulations. In this role, you will be responsible for keeping up with changing regulations, conducting research to identify potential impacts of those changes, and developing and implementing strategies to maintain compliance. If you are a detail-oriented problem solver with a passion for staying up to date on the latest regulatory developments, we want to hear from you!

Regulatory Affairs Specialist Duties:

• Assist in development of regulations, guidelines, and procedures.
• Develop project plans that integrate regulatory, safety, and mitigation requirements.
• Work with other regulatory and policy professionals to coordinate efforts.
• Assist in formulation of policies, regulations, and guidelines.
• Review regulations, reports, and legislation to identify potential impacts.
• Research and analyze integration of regulatory requirements and practices.
• Assist in review of procedures, implementation, compliance, and effectiveness.
• Develop procedures, tools, and systems for regulatory and policy compliance.
• Assist in preparation of regulatory and policy statements.
• Review regulatory reports for completeness and accuracy.
• Develop and maintain regulatory tracking systems.
• Provide regulatory guidance for system design, implementation, and operation.

Regulatory Affairs Specialist Responsibilities:

• Explore, evaluate, and proactively address worldwide regulatory issues and safety concerns.
• Identify and carry out legal, regulatory, and documentation requirements.
• Stay abreast of agency and organizational obligations and compliance requirements in all jurisdictions.
• Coordinate with legal, safety, compliance, and auditing departments.
• Prepare and maintain regulatory documentation for all products.
• Collaborate with regulatory affairs team and third parties to ensure regulatory reviews are complete and that regulatory information is complete and accurate.
• Coordinate with internal and external resources to meet audit and compliance requirements.
• Prepare and complete FDA and EMA submissions.
• Handle projects under tight schedules.

Requirements And Skills:

• Bachelor’s degree in science or related field.
• 2+ years experience in regulatory affairs.
• Ability to execute and handle regulatory submissions.
• Expert-level knowledge of FDA and DEA regulations.
• Experience with writing, editing, and formatting regulatory documents for submission to regulatory agencies.

At [Company Name], we are an Equal Opportunity Employer. We are committed to building a diverse and inclusive team. We encourage applications from people of all genders, and ages, as well as veterans and individuals of all races, religions, and national origins.