Acme Hiring Regulatory Affairs Officer

Acme Generics is a leading player in the pharmaceutical sector, specializing in delivering high-quality, compliant products for global markets. With a strong focus on innovation, regulatory excellence, and quality assurance, the company continues to expand its footprint across various countries, ensuring access to affordable medicines.

Responsibilities in the Job

As a Regulatory Affairs Officer, you will play a crucial role in ensuring regulatory compliance for pharmaceutical products. Key responsibilities include:

1. Dossier Compilation & Review:
   • Preparation, compilation, and review of dossiers in CTD, ACTD, and country-specific formats in line with international regulatory guidelines.
2. Interdepartmental Coordination:
   • Collaborate with departments like Production, Quality Assurance, Quality Control, Packaging, and Formulation Development to gather technical data.
3. ICH Guidelines Compliance:
   • Apply knowledge of ICH Guidelines (QSEM) required for Common Technical Document (CTD) preparation for pharmaceutical registrations.
4. Document Preparation:
   • Prepare and review SmPC (Summary of Product Characteristics), Package Inserts, and Labeling Information.
5. Dossier Submission:
   • Manage online applications and file dossiers for submission, specifically for the US market.
6. Query Handling:
   • Address and resolve queries received from clients and regulatory authorities (MOH).

Qualifications Required

To excel in this role, candidates should meet the following qualifications:

• A Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
• Relevant experience in Regulatory Affairs within the pharmaceutical industry.
• Strong understanding of ICH Guidelines and dossier formats (CTD, ACTD).

Skills Needed

• Proficiency in dossier preparation and regulatory submission.
• Strong communication and coordination skills for interdepartmental collaboration.
• Knowledge of international pharmaceutical regulations and country-specific guidelines.
• Hands-on experience with SmPC, Package Inserts, and Labeling Information.
• Problem-solving abilities to address regulatory queries efficiently.
• Familiarity with online submission platforms for the US and other markets.

Application Link

Advertisement