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Job Description:

The Regulatory Affairs Associate supports the regulatory team in ensuring that the company’s products comply with all applicable regulations and guidelines. This role involves preparing, reviewing, and submitting regulatory documents, as well as liaising with internal departments and external regulatory agencies to facilitate approvals for product registrations, changes, and renewals.

Key Responsibilities

Regulatory Submissions:

• Prepare and submit regulatory documents, including applications for product registrations, amendments, renewals, and post-market surveillance reports, to local health authorities.
• Ensure timely submission of all required documentation to regulatory agencies.
• Assist in obtaining product approvals (e.g. TFDA) and monitor the progress of submissions.

Documentation and Compliance:

• Review and maintain regulatory documentation, ensuring accuracy, completeness, and adherence to relevant regulations.
• Assist in the preparation of dossiers, technical files, and labeling in accordance with regional and international guidelines.
• Support audits and inspections conducted by regulatory authorities or internal teams.

Liaison with Regulatory Agencies:

• Communicate with regulatory bodies, such as the TFDA and others, to resolve queries and ensure approvals are obtained in a timely manner.
• Maintain positive relationships with regulatory authorities and stay updated on best practices and requirements.

Maintenance of Regulatory Databases:

• Maintain accurate and up-to-date databases of regulatory submissions, approvals, and other related documents.
• Track timelines for renewals, post-market reporting, and compliance deadlines.

Skills and Qualifications:

• Bachelor’s degree in life sciences, pharmacy, chemistry, or related field. An advanced degree may be preferred.
• 1-3 years of experience in regulatory affairs or related field (e.g., quality assurance, clinical research).
• Familiarity with global and local regulatory guidelines (e.g., FDA, EMA, ISO standards, ICH guidelines).
• Strong organizational skills and attention to detail.
• Excellent communication and interpersonal skills, with the ability to work in a cross-functional team environment.
• Proficiency in document management systems and regulatory submission software.
• Ability to manage multiple projects and prioritize tasks efficiently.
• Analytical mindset with problem-solving abilities.
• Pharmacist license is required