Key Responsibilities:

Regulatory Submission and Compliance

Prepare and compile registration dossiers in line with regulatory guidelines for submission to local and international regulatory agencies.

Ensure timely submission of all required documentation for product approval, renewal, and compliance.

Monitor the regulatory status of products, ensuring compliance throughout the product lifecycle, and implement any necessary updates to maintain market access.

Documentation and Record Management

Maintain up-to-date records and databases of product registration and compliance documentation.

Ensure that all documents meet internal quality standards and are aligned with regulatory requirements.

Assist in managing regulatory documentation changes, including variations and amendments, in accordance with regulatory guidelines.

Regulatory Intelligence and Strategy

Stay informed on regulatory changes, updates, and trends affecting product registration in target markets.

Assist in the development of regulatory strategies to support the registration of new products, product extensions, and renewals.

Provide recommendations to management regarding regulatory pathways, potential risks, and strategies to mitigate them.

Cross-functional Collaboration

Work closely with internal teams, including quality assurance, production, and R&D, to gather the required documentation and ensure regulatory requirements are met.

Liaise with regulatory authorities and external consultants to facilitate the product registration process.

Support product launches by ensuring regulatory approvals are obtained within the required timelines.

Qualifications:

Education: Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field; a Master’s degree or additional regulatory certification is a plus.

Experience:

Minimum of 3-5 years of experience in regulatory affairs, with a focus on product registration within the pharmaceutical industry.

Experience with regulatory submission processes for local and/or international markets.

Skills and Competencies:

Strong understanding of regulatory requirements, especially related to pharmaceuticals.

Excellent organizational, analytical, and communication skills.

Detail-oriented with the ability to manage multiple projects and deadlines.

Proficiency in regulatory submission software and MS Office.