Career as a Regulatory Affairs Manager


Summary

The Regulatory Affairs Manager is tasked with reviewing internal policies that usually relating to the manufacture, testing, marketing, and reliability of products to ensure that they are safe to use and work as intended. The regulatory affairs manager must keep abreast of legislative developments in the countries or regions in which a company distributes its products or services. Using this knowledge, the regulatory affairs manager examines all aspects of production, from discovery to distribution, to ensure compliance with regulatory statutes. Depending on the size and scope of the business, the regulatory affairs manager may need to maintain a complete understanding of many different regulatory processes of state, national, and/or international bodies.

The Regulatory Affairs Manager helps control a large part of their company's reputation with legislators and the public, which means they must maintain excellent records and create methods that quickly address potential violations. The regulatory affairs manager oversees all teams involved in production, marketing, and distribution to verify that all are operating according to regulations. They will also advise and strategize with upper management, keeping them informed of regulatory developments and advising them on methods to execute contingency methods as needed.

The duties of Regulatory Affairs Manager is to oversee preparation, data, testing procedures, and compliance aspects of proposals and reports. They also investigate and report adverse events, compliance violations and similar problems and work directly with departments and project personnel to ensure compliance and inform of updates to regulations. To ensure that projects and proposals meet all relevant guidelines, standards, and regulatory rules, conducting research where needed.

Work Environment

Working hours can include regular extra hours to meet tight deadlines, but not weekends or shifts. There are also some opportunities for part-time work.

Entry Level Education

  • Bachelor’s Degree B.Sc - Any Specialization, B.Pharma – Pharmacy.
  • Master’s Degree in MS/M.Sc(Science) - Any Specialization, M.Pharma – Pharmacy.

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