Regulatory Affairs

Regulatory affairs professionals ensure that new drugs and medical devices are both safe and effective for use in their target patient population. They work throughout the product life cycle, from development and testing to the approval process to post-market monitoring.
Regulatory affairs professionals may specialize in a particular geographic area, in a product development phase (non-clinical, clinical, chemicals manufacturing and controls, post-approval), or in particular product type (small molecule drugs, biologics, medical devices, generic drugs).

Typical Job Duties

  • Reviewing applications for new drugs from pharmaceutical companies to approve new products that are safe and effective.
  • Monitoring changes in regulatory requirements, providing comments on new draft guidances, and advising companies of the impact of new regulations.
  • Preparing regulatory submissions for approval to market a new product in a particular country, including all the appropriate testing documentation.
  • Providing expertise on regulatory compliance throughout the product development cycle.

Technical Skills

  • Interest in regulations, especially in keeping up with the details of new and changing regulations.
  • Excellent written communication skills, both in writing documents and reading and understanding complex regulations.
  • Ability to read and understand complex, and sometimes conflicting, requirements and develop a compliance plan.
  • Excellent oral communication skills for discussing options and requirements with other scientists and business managers, sometimes under tight time pressures.
  • Persuasion and negotiating skills.
  • Strong sense of ethics and the self-confidence to stand firm when required.
  • Teamwork skills, to coordinate with scientists, engineers, managers, and regulatory agency personnel.

Career Path

The vast majority of regulatory affairs professionals transition into this field after working as a bench scientist for a number of years. They usually transition within the same company after gaining experience in regulatory affairs, for example, by helping to author a new drug application for a compound they have been working on or by shadowing someone in the regulatory affairs department. After they have transitioned out of the laboratory, there is generally no going back. Advancement in regulatory affairs involves more responsibility, both in working on larger and more complex projects and in supervising more junior professionals.

Original content at acs.org

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