Job Description
A dynamic and successful pharmaceutical company seeks a passionate and technically strong individual to support their growing business.
If you enjoy a varied workday focusing on different areas across Quality and Regulatory, this could be an excellent opportunity for you.
As part of the Quality team, you will play a key role in supporting the US side of the business by ensuring compliance with cGMPs & Environmental, Health & Safety regulations.
You will also:
* Ensure compliance with the company's Quality Management System.
* Support document reviews to ensure timely release of finished product.
* Execute all regulatory updates to product labelling to ensure timely and compliant launch of finished products.
* Manage and execute all routine regulatory updates and submissions of finished product labelling.
* Creation and maintenance of National Drug Codes & Universal Product Codes.
* Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
* Ensure the company and product are registered in the appropriate markets as required.
* Reviews and approves product labelling, patient package insert and other product labelling.
Requirements:
* Minimum requirement of a BSc in a scientific discipline and a minimum of 4 years within a Quality Assurance role.
* Ability to effectively manage and participate in cross-functional problem-solving teams.
* Ability to work independently.
* Excellent teamwork and interpersonal skills.
* Ability to handle a variety of tasks simultaneously.
* Artwork review/Regulatory experience desirable.
* Strong knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs.