Job Description

SASMAR is seeking a skilled and organized Regulatory Affairs Coordinator specializing in Registrations and Compliance to join our expanding team. We are a leading pharmaceutical company focused on personal care and fertility products, including our flagship Conceive Plus brand, with products available in over 70 countries worldwide. Our commitment to regulatory excellence and market compliance is key to our continued global success.

In this role, you will oversee and coordinate regulatory registrations and compliance activities across multiple markets, ensuring that all products meet the necessary regulatory requirements. You will work closely with internal departments and external partners to facilitate smooth and timely product registrations and maintain compliance with evolving regulatory standards.

Key Responsibilities

• Coordinate and manage product registration processes and regulatory submissions in various target markets.
• Maintain up-to-date knowledge of local and international regulatory requirements and ensure company compliance.
• Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, and Marketing to prepare necessary documentation.
• Track and monitor registration status, renewals, and compliance timelines to ensure timely approvals and market access.
• Support regulatory audits and inspections by preparing required documentation and facilitating communication with authorities.
• Assist in developing and implementing regulatory strategies to support market expansion and compliance objectives.
• Maintain and update regulatory databases and filing systems.
• Communicate with regulatory authorities and in-market representatives as needed.
• Provide training and guidance on compliance requirements to internal stakeholders.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• Minimum 2 years of experience in regulatory affairs coordination, preferably within pharmaceutical or consumer health industries.
• Strong knowledge of international regulatory registration and compliance requirements.
• Excellent organizational and project management skills with attention to detail.
• Proficient in managing regulatory documentation and databases.
• Effective communication and interpersonal skills for collaboration with internal teams and external authorities.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience with regulatory submissions software and databases is a plus.
• Fluency in English; additional languages are advantageous.
• You must have full permission to live and work in Malta without a permit.

Benefits

• Competitive salary
• English language and multi-cultural work environment
• Private Health Insurance (medical, dental, hospitalisation)
• Career advancement opportunities in stable company
• Modern offices, convenient to public transport.