SASMAR
pharmaceutical
RegulatoryAffairsCoordinator,RegistrationsandCompliance
“Regulatory Affairs Coordinator, Registrations and Compliance at SASMAR. Skills: Regulatory Affairs, Registrations, Compliance. 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.”
What You'll Achieve.
ensuring that all products meet the necessary regulatory requirements.; facilitate smooth and timely product registrations and maintain compliance with evolving regulatory standards.; ensure timely approvals and market access.; support market expansion and compliance objectives.
Industry & Context.
You must have full permission to live and work in Malta without a permit.
What They're Looking For.
Must Have
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., 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., You must have full permission to live and work in Malta without a permit.
Nice to Have
Experience with regulatory submissions software and databases is a plus., Fluency in additional languages are advantageous.
What You'll Do.
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.
Track and monitor registration status
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.
How You'll Work.
Team & Collaboration
Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, and Marketing to prepare necessary documentation.; collaboration with internal teams and external authorities.
Communication Scope
Effective communication and interpersonal skills for collaboration with internal teams and external authorities.; Communicate with regulatory authorities and in-market representatives as needed.
Process & Methodology
project management skills
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