Regulatory Affairs Specialist

SASMAR is currently seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist. We are a reputable pharmaceutical company that specializes in personal care and fertility products, including our renowned Conceive Plus brand. Our products are distributed in over 70 countries through various channels such as supermarkets, clinics, hospitals, pharmacies, and drugstores.

As a Regulatory Affairs Specialist at SASMAR, you will play a vital role in ensuring compliance with global regulatory requirements and supporting the registration and approval of our products in various markets. This position involves preparing and submitting regulatory documents, managing product registrations, and staying up-to-date with regulatory changes and industry trends.

At SASMAR, we value diversity and inclusion. We provide a supportive and collaborative work environment that promotes personal and professional development.

Responsibilities

• Prepare and submit regulatory documents, including product registration dossiers and variations.
• Responsible for supporting the management of in-market representative bodies.
• Manage the regulatory approval process for new products and line extensions.
• Ensure compliance with global regulatory requirements and standards, including FDA, EMA, AFMPS, TGA and other relevant agencies.
• Provides regulatory guidance and training as appropriate ensuring compliance with all regulatory requirements in existing and new markets.
• Manages entry of data into WERC’S and generates SDS’s as appropriate.
• Reviews global regulations/guidance documents and works with his/her supervisor and colleagues as appropriate to develop strategies that ensure ingredient, packaging component, printing inks/pigments and finished product compliance.
• Review and interpret regulatory guidelines and communicate requirements to cross-functional teams.
• Collaborate with cross-functional teams to support product development and quality assurance initiatives.
• Monitor and track the progress of regulatory submissions and provide status updates.
• Stay up-to-date with regulatory changes, guidance, and industry best practices.
• Participate in regulatory inspections and audits as required.
• Maintain and update regulatory documentation and databases.

Requirements

• Minimum 2 years’ experience in a regulatory role
• Formal education in a related field
• Hands-on working knowledge of domestic FDA OTC drug product requirements
• Experience with quality inspections and certification audits
• Strong knowledge of cGMPs
• Experience with REACH law and WERCs
• Experience writing SOPs
• Statistical evaluation of data
• Strong computer skills utilizing a Microsoft environment (Word, Excel, Access, PowerPoint)
• Experience using databases and digital files to create reports and regulatory dossiers
• Experience working with external regulatory bodies and in-market representatives to maintain product registrations in local markets
• Strong written and spoken English
• Eligible to work in Malta

Benefits

• 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.

This position is based at our new villa offices in Ta' Xbiex, Malta.