Regulatory Affairs Specialist for Pharmaceutical Registration
22 hours ago
Company Overview
Acme Generics is a leading provider of generic pharmaceuticals, dedicated to delivering high-quality products that meet the needs of patients and healthcare professionals.
About the Role
We are seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring the registration of our pharmaceutical products with regulatory authorities around the world.
Job Responsibilities
Your primary responsibilities will include:
Compilation, preparation, and review of dossiers in CTD and ACTD formats, as well as country-specific documents, in accordance with regulatory guidelines.
Active coordination with internal departments, including Production, Quality Assurance, Quality Control, Packaging, and Research and Development, to ensure technical data requirements are met.
Familiarity with ICH Guidelines (QSEM) is required for Common Technical Document (CTD) preparation and submission for human pharmaceuticals registration.
Preparation and review of SmPC, Package Insert, and labeling information to ensure compliance with regulatory requirements.
Knowledge of online application processes for dossier submission in the US and other countries.
Handling queries received from clients and regulatory authorities in a timely and professional manner.
Requirements
To be successful in this role, you will need:
A strong background in regulatory affairs, preferably with experience in pharmaceutical product registration.
Detailed knowledge of ICH Guidelines (QSEM) and Common Technical Document (CTD) preparation.
Excellent communication and project management skills, with the ability to work effectively in a team environment.
Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.
A solid understanding of regulatory guidelines and requirements for pharmaceutical product registration.
What We Offer
In return for your expertise, we offer a competitive salary range of $80,000 - $110,000 per annum, depending on your level of experience. You will also have access to ongoing training and development opportunities, a comprehensive benefits package, and the chance to work with a dynamic team of professionals in the pharmaceutical industry.
Location
This role is based in our headquarters, located in [insert location].
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