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.
...information and links are included), to be considered for this position.*** Job Classification: Firefighter / Paramedic & Firefighter / EMT - B The City of Wylie requires FireTEAM and valid physical agility. All testing must be completed by the close date of March...
...possibility of extension based on performance. Job Overview: We are looking for a detail-oriented and self-motivated Virtual Data Entry professional to join our team. As a Virtual Data Entry, you will be responsible for accurately and efficiently entering data...
In House Counsel Jobs New York | JDHuntr 38453 Alternate Contract Manager, Oklahoma City, OK To apply go to JDHuntr.com Assist running a large mortgage servicing program and provide back-up to the Contract Manager. Providing project management, strategic planning...
...City Rochester State MN Remote NO Department Nursing Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are...
...Data Engineer, Python & ETL, Chicago, IL A proprietary trading firm is seeking a Data Engineer, Python & ETL to join its Data Infrastructure... ..., Data Models, ETL, Programmer Analyst, Programming, Software Developer, Trading, Financial, Chicago Recruiters, Information Technology...