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What Does a Regulatory Affairs Specialist Do?

Regulatory affairs specialists within the medical industry often ensure the correct handling of drugs.
Government regulated industries like the banking, pharmaceutical and energy sectors staff specialists to ensure compliance.
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  • Written By: Cassie L. Damewood
  • Edited By: Jenn Walker
  • Last Modified Date: 12 December 2014
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A regulatory affairs specialist makes sure his company strictly follows government rules and regulations relevant to company goals and operations. He can work in a variety of government-regulated industries, including banking, pharmaceuticals, energy or medical devices industries. His role often involves extensive interaction with regional and national regulatory agencies. The specialist is expected to keep his company up-to-date on regulatory policy and procedural changes that could affect them, either positively or negatively. He is also required to provide feedback on pertinent issues and defend his company’s interests and positions.

If his company proposes to introduce new products or services, or plans activities outside the norm, the regulatory affairs specialist presents a proposal of action to the agencies. He ensures the plan complies with corporate guidelines for submission and meets government standards. Interaction with lower-level approval teams is generally required prior to making his presentation for final approval.

This position requires assertive and polished communication skills. The specialist provides input on teams that determine regulatory requirements that affect his company’s, as well as his country’s, market position. His participation and the clout he brings to the negotiations affect the international market’s present and future direction. Well-written and thoroughly researched reports, along with thought provoking oral presentations are required to be a successful regulatory affairs specialist.

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Since so many issues and regulations that affect international trade and political repercussions are at hand, a regulatory affair’s specialist must be extremely well-read on international affairs. He should be well informed on trade, commerce and industry trends, as well as public perception and attitudes. Acute analytical skills and sharp policy interpretation abilities are highly desirable traits for this position.

Ensuring all documentation is complete and filed in a timely manner is an important part of a regulatory affairs specialist’s job. An important part of his work is to procure and file licenses and legal documents regarding the sales and transport of his company’s products. Involvement in this process also provides him with the opportunity to spot questionable directives and statutes and efficiently address points of concern.

In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling. He needs to discuss these finer points with his colleagues and associates to determine their positions. Once a consensus is reached, they can address contentious issues with a united front and present a strong solidarity in presentations and debates. These specialists develop strategies among themselves that often involve mutually conciliatory positions and stances.

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anon316887
Post 1

What if I am a non-native English speaker? I am pretty fluent in English but definitely can't speak like native speakers. Does this mean that it would be better for me to look for another job?

I am working in pharma R&D with a masters degree. I guess that satisfies some qualifications.

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