**Job Summary:**
We are seeking a highly skilled and motivated Commercial Pharmaceutical Specialist to join our client, a well-established global pharmaceutical organisation. As a key member of the commercial team, you will play a critical role in ensuring compliance with regulatory and quality standards for commercial activities related to the distribution, sale, and marketing of pharmaceutical products.
The ideal candidate will have a strong understanding of commercial processes, including supply chain management, distribution, marketing, and sales activities within the pharmaceutical industry. You will oversee the release of pharmaceutical products for commercial distribution, ensuring that all necessary documentation and testing have been completed in accordance with applicable regulations and company standards.
Key Responsibilities:
* Serve as the designated Commercial Qualified Person (QP) for the company, responsible for ensuring compliance with all relevant regulatory requirements and guidelines.
* Oversee the release of pharmaceutical products for commercial distribution, ensuring that all necessary documentation and testing have been completed in accordance with applicable regulations and company standards.
* Review and approve commercial documentation, including batch records, labelling, packaging, and distribution records, to ensure accuracy, compliance, and alignment with regulatory requirements.
* Collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and marketing, to support commercial activities and resolve any quality-related issues.
Requirements:
* Bachelor's degree in pharmacy, pharmaceutical sciences, or a related field. Advanced degrees and certifications are a plus.
* Prior experience as a Qualified Person (QP) within the pharmaceutical industry, with a focus on commercial activities, is essential.
* In-depth knowledge of global regulatory requirements, including but not limited to EU GMP, FDA regulations, ICH guidelines, and other relevant industry standards.
* Strong problem-solving skills and the ability to drive continuous improvement initiatives.
What We Offer:
* A competitive salary of $120,000 per annum, commensurate with experience.
* A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
* Opportunities for career growth and development within our organisation.