Regulatory Affairs Executive

As a Regulatory Affairs Executive, you will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is responsible for the company’s regulatory processes and reporting of the regulatory activities.

Responsibilities

• Ensuring compliance with all regulatory requirements
• Preparation and submission of all regulatory reports
• Providing accurate reviews of data and reports
• Ensuring accurate and timely submissions to regulatory agencies
• Advising others on regulatory and compliance matters
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Coordinate, prepare, or review regulatory submissions for projects.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Determine the types of regulatory submissions or internal documentation that are required in changes.
• Identify relevant guidance documents, international standards, or consensus standards.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Compile and maintain regulatory documentation databases or systems.
• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  
  

Qualifications

• Bachelor’s degree in a scientific field such as Pharmacy
• Two years of experience in a similar role
• Excellent verbal and written communication skills
• Strong interpersonal skills
• Excellent customer service skills
• Strong problem-solving skills
• Excellent organizational skills
• Highly developed attention to detail
• Strong project management skills
• Ability to work well in a team environment