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Title
Text copied to clipboard!Regulatory Affairs Consultant
Description
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We are looking for a knowledgeable Regulatory Affairs Consultant to guide our company through the complex maze of regulations and procedures. This role involves ensuring that our company adheres to all the regulations and laws pertaining to our business. You will be responsible for advising on and coordinating the approval of products from inception to market, as well as compliance with regulations set by a variety of regulatory agencies. You will also be tasked with staying abreast of regulatory procedures and changes in regulatory climate and advising the company accordingly. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and a keen eye for detail.
Responsibilities
Text copied to clipboard!- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Advise on the regulatory aspects and climate that would affect proposed activities.
- Identify relevant guidance, regulations and standards to ensure product compliance.
- Prepare and submit documentation to regulatory agencies.
- Ensure compliance with regulations set by a variety of regulatory agencies.
- Monitor and improve tracking/control systems.
- Keep up to date with changes in regulatory legislation and guidelines.
- Analyze complicated information, including trial data.
- Offer strategic advice to senior management throughout the regulatory approval process.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Requirements
Text copied to clipboard!- Bachelor's degree in a related field.
- Proven experience in a regulatory role.
- Strong knowledge of the industry and its regulations.
- Excellent communication and negotiation skills.
- Strong analytical and problem-solving skills.
- Ability to stay updated on trends and developments within the field.
- Proficient in documentation and reporting.
- Good organizational skills.
- Ability to work within strict deadlines.
- High attention to detail.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with regulatory submissions?
- How do you stay updated on changes in regulatory legislation and guidelines?
- Can you discuss a time when you had to advise on a regulatory aspect that affected a proposed activity?
- How do you handle the pressure of strict deadlines?
- Can you describe a time when your attention to detail was critical to your role?