Regulatory Affairs Associate
A Regulatory Affairs Associate is responsible for ensuring that products meet all of the regulatory standards and requirements set by government bodies before they can be marketed or sold.
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Sample Job Descriptions for Regulatory Affairs Associate
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
The Regulatory Affairs Associate will assist in the preparation of regulatory submissions and communications with regulatory agencies under supervision. This entry-level position is designed to develop a working knowledge of regulatory procedures and guidelines and to contribute to strategic regulatory approaches for the development of products.
Required Skills
- Written and verbal communication
- Time management
- Critical thinking
- Team collaboration
- Project management
- Regulatory knowledge
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field.
- Understanding of regulatory guidelines and directives.
- Excellent communication and organizational skills.
- Ability to work in a team environment.
- Detail-oriented with the ability to handle multiple tasks.
- Proficiency in Microsoft Office Suite.
Responsibilities
- Assist in the preparation of documentation for regulatory submissions.
- Communicate with regulatory agencies under the guidance of senior staff.
- Review and compile regulatory data from different departments.
- Ensure compliance with regulatory agency guidelines and internal SOPs.
- Participate in regulatory team meetings and provide input on regulatory strategies.
- Support post-marketing regulatory activities as needed.
Intermediate (2-5 years of experience)
Summary of the Role
The Regulatory Affairs Associate will be responsible for ensuring that the company's products comply with all regulations and laws pertaining to their development, manufacture, and distribution. The role involves coordinating submissions to regulatory agencies, reviewing product changes for impact on regulatory filings, and maintaining regulatory documentation.
Required Skills
- Strong organizational and communication skills.
- Ability to work effectively in a team environment and interact with all levels of management.
- Strong analytical and problem-solving abilities.
- Proficiency with electronic submission software and document management systems.
- Familiarity with GxP (Good Practice) requirements.
- Excellent writing skills for the preparation of regulatory documents.
Qualifications
- A bachelor's degree in life sciences, pharmacy, or a related field.
- At least 2 years of experience in regulatory affairs or a related field.
- Knowledge of FDA, EMA, and other regulatory body's guidelines and regulations.
- Experience with regulatory submissions and knowledge of submission formats (e.g., NDA, ANDA, BLA, 510(k), PMA).
- Proven ability to manage multiple projects at once while paying strict attention to detail.
Responsibilities
- Prepare and submit regulatory submissions to obtain and maintain approvals for product marketing.
- Ensure compliance with regulatory agency regulations and interpretations.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Analyze product changes for impact on regulatory filings worldwide.
- Communicate with regulatory and government agencies regarding pre-submission strategies, potential regulatory pathways, and compliance test requirements.
- Participate in internal audits and inspections.
- Maintain an up-to-date understanding of laws, regulations, and guidelines, interpreting regulatory rules or rule changes and ensuring that they are communicated through corporate policies and procedures.
Senior (5+ years of experience)
Summary of the Role
The Regulatory Affairs Associate will be responsible for ensuring that products meet all of the necessary regulatory standards and compliances. The associate will work closely with regulatory agencies, manage product submissions, and keep up-to-date with changing regulations in the industry.
Required Skills
- Excellent communication and interpersonal skills to effectively interface with regulatory agencies and all levels within the company.
- Strong organizational skills and attention to detail.
- Ability to work independently and as part of a team in a dynamic environment.
- Proficient in the use of electronic submission management systems and tools.
- Critical thinking and problem-solving skills.
Qualifications
- Bachelor's degree in relevant field such as biology, chemistry, pharmacology, or related scientific field.
- 5+ years of experience working in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Strong understanding of international regulations and guidelines that affect their industry and product lines.
- Proven track record of managing multiple projects in a deadline-driven environment.
Responsibilities
- Coordinate and prepare document packages for regulatory submissions from all areas of the company.
- Communicate with regulatory agencies as needed regarding registration and compliance issues.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Work with cross-functional teams to ensure that products comply with all regulations and laws pertaining to the company.
- Review product labels, marketing materials, and websites to ensure compliance with regulatory requirements.
- Advise on legal and regulatory aspects of product development and introduction.
- Participate in the development and updating of standard operating procedures and regulatory policies.
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