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Title
Text copied to clipboard!Regulatory Affairs Specialist
Description
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We are looking for a detail-oriented Regulatory Affairs Specialist to ensure our company adheres to legal standards and in-house policies. You will be responsible for enforcing regulations in all aspects and levels of business as well as provide guidance on compliance matters. A great Regulatory Affairs Specialist is well-versed in legal guidelines and corporate governance best practices. They are professionals of high ethical standards and work diligently to complete their duties keeping in mind the objectives of the business. You must be comfortable saying 'no' when necessary and be result-oriented.
Responsibilities
Text copied to clipboard!- Develop and implement company policies and regulations.
- Understand and follow current regulations and assist in the compliance of regulatory affairs.
- Work with internal teams to gather necessary information for regulatory documentation.
- Prepare and submit documentation to regulatory agencies.
- Ensure that the company's products comply with the regulations of regulatory agencies.
- Review and set the standards for the dissemination of the company's product information.
- Monitor and set timelines for licensing renewals.
- Develop strategies and plans for regulatory affairs.
- Keep up-to-date with international legislation, guidelines and customer practices.
- Collect, collate and evaluate scientific data that has been researched by colleagues.
Requirements
Text copied to clipboard!- Bachelor's degree in law, business administration or related field.
- Proven experience as a Regulatory Affairs Specialist.
- Excellent knowledge of reporting procedures and record keeping.
- A business acumen partnered with a dedication to legality.
- Methodical and diligent with outstanding planning abilities.
- An analytical mind able to 'see' the complexities of procedures and regulations.
- Excellent communication skills.
- Integrity and professional ethics.
- Teamwork skills.
- Attention to detail.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with regulatory affairs?
- How do you handle the pressures of meeting regulatory deadlines?
- Can you describe a time when you had to enforce a policy that was not popular, and how you handled it?
- How do you stay updated on current regulations and changes in the law?
- Can you describe a time when you had to make a difficult decision that was legal, but may not have been popular within the company?