SASMAR is actively seeking a dedicated and detail-oriented Regulatory Affairs Specialist to join our Regulatory department. As a leading pharmaceutical company specializing in personal care and fertility products, including the acclaimed Conceive Plus brand, we have established a strong presence in over 70 countries. Our commitment to innovation and quality ensures that our products are available through various channels, from supermarkets and pharmacies to clinics and hospitals.
In the role of Regulatory Affairs Specialist, you will be instrumental in ensuring our products meet all necessary regulatory requirements for various global markets. This includes preparing and submitting essential regulatory documents, managing product registrations, and keeping abreast of evolving regulatory landscapes.
At SASMAR, we prioritize a culture of collaboration and growth, offering a supportive environment where your expertise can thrive.
Prepare and submit regulatory documents including product registration dossiers and variations.
Oversee the regulatory approval process for new products and line extensions.
Ensure compliance with international regulatory guidelines from agencies such as FDA, EMA, AFMPS, and TGA.
Provide regulatory guidance and training to ensure adherence to regulations across all markets.
Maintain accurate records and manage data entries into WERC's, generating Safety Data Sheets (SDS) as required.
Review and interpret regulations to develop compliant strategies for ingredients, packaging, and finished products.
Collaborate with cross-functional teams to support product development and quality assurance initiatives.
Monitor the status of regulatory submissions and provide updates as needed.
Stay informed on regulatory changes and industry best practices.
Participate in regulatory inspections and audits.
Maintain and update regulatory documentation and databases.
Bachelor's degree in a relevant field, such as life sciences or pharmacy.
Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical or personal care industry.
In-depth knowledge of Medical Devices, Food Supplement regulations and requirements.
Experience with 9001 / 13485 quality inspections and compliance audits.
Strong understanding of cGMPs and REACH regulations.
Proficient in writing Standard Operating Procedures (SOPs).
Excellent written and verbal communication skills.
Strong analytical and problem-solving skills with the ability to manage multiple projects.
Advanced computer skills, including Microsoft Office Suite (Word, Excel, PowerPoint, Access) and database management.
Ability to work independently and as part of a collaborative team.
This position is based at our new villa offices in Ta' Xbiex, Malta.
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