Regulatory Affairs Specialist JOB DESCRIPTION GUIDE

Regulatory Affairs Specialist Salary Guide

Looking to hire top talent or advance your career? Our expertly researched salary guide for 2024 provides valuable insights into Legal and Compliance positions!

Regulatory Affairs Specialist Core Duties and Qualifications

It is the Regulatory Affairs Specialist that is in a position of offering support to an organizations compliance with the many regulations and code especially of industries in the pharmaceutical business, the manufacturing industries in the medical field, foods industry among other fields.

Among all these activities it has very crucial function in ensuring preparation and submission of documents and support to the government agencies to show compliance with safety and efficacy of products.

Desired Profile For A Regulatory Affairs Specialist

Roles and Duties

Some examples of the tasks and responsibilities are drafting and filing regulatory papers, conformity and checking out for alterations in legislation that might affect the firm as well as following:

Preparation and submission of documentation to attain approval of a product to the appropriate organizations.
Keep the company’s products and processes in compliance with regulations and standards.
Update policies according to the trends and updates in the standards and rules.
Regular consultation with regulatory authorities and maintain active communication with them.
Perform compliance audits and develop reports and data for management.
Advise on applicable regulatory standards to be followed during new product development.
Assist in finding solutions to legal problems using specific strategies.

Qualifications And Certifications

An individual must possess the following educational qualifications and certifications for the role of regulatory affairs specialist:

Required bachelor’s degree or equivalent in:
- Law
- Life Sciences
- Pharmacy Biotechnology
Advanced law degree in regulatory affairs, law, or related fields is preferred.
Professional certifications such as Regulatory Affairs Certification (RAC), Certified in Regulatory Compliance Management (CRCM), Certified Regulatory Affairs Manager (CRAM), Certified Regulatory Affairs Associate (CRAA), and others are suggested.

Skills And Expertise

Below outlined skills and experience are required for the role of regulatory affairs specialist:

2-5 years of professional experience in regulatory affairs, quality assurance, or related fields.
Familiarity with regulatory agencies like FDA, EMA, etc.
Strong knowledge of rules and standards of the industry.
Good communication and leadership skills.
Strong analytical thinking to interpret data.
Risk assessment and problem-solving skills.
Attention to detail.
Strong moral values and integrity.

RFS HR Consultancy, a Premier Legal and Compliance Recruitment Provider in the UAE, specializes in connecting top legal companies with talented legal and compliance professionals.

Explore our platform for the latest legal and compliance positions at top legal firms.

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