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Regulatory Affairs Specialist Assistant Job Description

Job Title: Regulatory Affairs Specialist Assistant

Overview/Summary of the role:

The Regulatory Affairs Specialist Assistant is responsible for assisting the Regulatory Affairs Specialist in ensuring that a company complies with all regulations, policies and guidelines on local, state and federal levels. This includes reviewing and evaluating regulatory policies, procedures and guidelines that impact the company’s operations. They also provide support for the ongoing development, submission and maintenance of regulatory approvals and applications.

Responsibilities and Duties:

• Conduct research into regulatory procedures in order to accurately interpret and explain regulations.
• Track and monitor changes to regulatory guidelines and policies.
• Ensure that regulatory timelines are met.
• Assist in the compilation and submission of regulatory filing of products and devices.
• Review and provide comments on documentation.
• Responsible for ensuring compliance with all regulatory requirements.
• Maintain a comprehensive record-keeping system for all regulatory compliance documents.

Qualifications and Skills:

Hard Skills:

• Knowledge of FDA regulatory requirements and ICH guidelines
• Strong analytical and research skills
• Ability to interpret and explain regulatory procedures and policies
• Strong problem-solving skills
• Proficient in Microsoft Office Suite including Word, Excel, and PowerPoint

Soft Skills:

• Attention to detail
• Strong communication and interpersonal skills
• Strong organizational and time management skills
• Ability to work in a fast-paced environment

Education and Experience:


• Bachelor’s degree in a scientific or technical field such as Biology, Chemistry, or any other closely related scientific field
• 0-2 years of experience in regulatory affairs
• Knowledge of FDA regulations and guidelines


• Master’s degree in a scientific or technical field such as Biology, Chemistry, or any other closely related scientific field
• 2+ years of experience in regulatory affairs
• RAC (Regulatory Affairs Certification) preferred.

Licensing (if applicable):
Depending on the industry, regulatory affairs specialist assistants may need to obtain certain certifications or licenses to work in their role. For example, professionals working in the pharmaceutical industry may need to obtain certification from the Regulatory Affairs Professionals Society (RAPS) to demonstrate their knowledge and expertise in the field.

Typical Employers:
Regulatory affairs specialist assistants can find employment opportunities in a range of industries, including pharmaceuticals, biotechnology, medical devices, food and beverage, and cosmetics. They may work for companies of various sizes, from startups to multinational corporations. Other potential employers include regulatory agencies, consulting firms, and contract research organizations (CROs).

Work Environment:
Regulatory affairs specialist assistants typically work in office settings and may spend the majority of their time on the computer or on the phone communicating with regulatory agencies or colleagues. They may also need to attend meetings or conferences related to regulatory affairs. The work can be fast-paced and may involve tight deadlines and pressure to meet regulatory requirements.

Career Pathways (leading to this position and next positions):
To become a regulatory affairs specialist assistant, individuals may need a bachelor's degree in a relevant field such as biology, chemistry, or public health. Some employers may also require previous experience in regulatory affairs or a related field. With experience and additional education or certifications, regulatory affairs specialist assistants may be able to advance to higher-level positions, such as regulatory affairs specialist, regulatory affairs manager, or director of regulatory affairs.

Job Growth Trend (USA and Global):
According to the Bureau of Labor Statistics, employment of regulatory affairs specialists is projected to grow 3 percent from 2019 to 2029, which is about as fast as the average for all occupations. This growth may be attributed to the increasing complexity of regulations and the need for companies in various industries to comply with these regulations. The job growth trend may vary depending on the specific industry and region.

Career Satisfaction:
As a Regulatory Affairs Specialist Assistant, the level of job satisfaction can vary depending on the specific company and industry you are working in. It can be rewarding to play an important role in ensuring regulatory compliance and supporting the distribution of safe and effective products. However, it can also be challenging with a high level of attention to detail and the need to navigate complex regulations.

Related Job Positions:
Some related job positions are:
1. Regulatory Affairs Specialist
2. Quality Assurance Specialist
3. Compliance Associate
4. Research and Development Assistant
5. Clinical Trials Coordinator

Connected People:
As a Regulatory Affairs Specialist Assistant, you would be interacting with various stakeholders such as:
1. Regulatory Affairs Manager/ Director
2. Quality Assurance Manager
3. Compliance Officer
4. Research and Development team
5. Clinical Trials team
6. Technical writers
7. Production team

Average Salary:
The average salary for a Regulatory Affairs Specialist Assistant varies based on location and seniority level:

- USA: $50,000 - $70,000 per year
- UK: £25,000 - £35,000 per year
- Germany: €35,000 - €45,000 per year
- India: INR 4,00,000 - INR 7,50,000 per year
- Brazil: R$50,000 - R$70,000 per year

Benefits Package:
The benefits package for a Regulatory Affairs Specialist Assistant typically includes health insurance, retirement plans, paid time off, and potentially educational opportunities. Some companies may also offer bonuses or performance-based incentives.

Schedule and Hours Required:
The schedule and hours required for a Regulatory Affairs Specialist Assistant can vary based on the company's needs and projects. Typically, it would be a full-time position with standard business hours. Some overtime may be required to meet project deadlines, and occasional travel may be necessary for attending conferences or meetings.

Level of Autonomy:
As a Regulatory Affairs Specialist Assistant, the level of autonomy can vary depending on the company you work for and the specific job responsibilities. Generally, this role works under the supervision of a Regulatory Affairs Specialist or Manager and follows established regulations and procedures. However, the level of autonomy can increase with experience and knowledge of the regulatory landscape.

Opportunities for Professional Development and Advancement:
There are various opportunities for professional development and advancement in the field of regulatory affairs. As an assistant, you will gain valuable experience and knowledge of regulatory processes, which can help you advance to a Regulatory Affairs Specialist role. Additionally, there are certifications offered by professional organizations such as RAPS (Regulatory Affairs Professionals Society) that can help you advance your career.

Specialized Skills or Knowledge Required:
To be successful in a Regulatory Affairs Specialist Assistant position, you should have a strong understanding of FDA regulations, guidelines and laws pertaining to medical devices, pharmaceuticals, or other regulated products. Attention to detail, strong communication skills, and critical thinking skills are also important.

Physical Demands:
The physical demands of working as a Regulatory Affairs Specialist Assistant are typically minimal. The job is primarily desk-based and does not require extensive physical activity.

Tools and Technologies Used:
As a Regulatory Affairs Specialist Assistant, you will use various tools and technologies to manage and organize regulatory information. This may include software such as Microsoft Excel or document management systems, as well as web-based regulatory databases and communication tools. A high level of proficiency in Microsoft Office Suite is typically required.

Work Style:
A Regulatory Affairs Specialist Assistant typically works in a fast-paced environment and is required to handle multiple tasks simultaneously. They should be detail-oriented, follow a systematic approach to their work, and possess strong analytical skills to ensure that all regulatory submissions are compliant with regulatory requirements. Additionally, they should be able to adapt to changing regulatory environments and be able to incorporate new regulations and guidelines into their work.

Working Conditions:
A Regulatory Affairs Specialist Assistant can work in various settings such as pharmaceutical companies, medical device companies, and biotechnology firms. They may be required to travel occasionally to attend regulatory meetings or conferences. The work may involve sitting for long periods, and they may require working overtime, especially when regulatory filings are due.

Team Size and Structure:
A Regulatory Affairs Specialist Assistant will typically work as part of a team that includes Regulatory Affairs Managers, Directors, and Product Development teams. They may also collaborate with other departments, including Clinical Development, Quality Assurance, and Manufacturing.

Collaboration and Communication Requirements:
Regular communication and collaboration with internal and external stakeholders are vital for the success of Regulatory Affairs Specialist Assistants. They should have excellent written and verbal communication skills to draft and review regulatory documents and to work effectively with cross-functional teams. They should also be able to build strong relationships with regulatory authorities and regulatory consultants.

Cultural Fit and Company Values:
Regulatory Affairs Specialist Assistants should share the company's vision, mission, and values related to regulatory compliance and quality. They should be committed to promoting high standards of regulatory excellence and have a strong work ethic. Additionally, they should possess excellent interpersonal skills, be proactive, and be able to work collaboratively to achieve team goals.