Join a leading team dedicated to navigating the regulatory landscape within the pharmaceutical industry. Engage in meaningful work that impacts the development and delivery of life-saving products while ensuring adherence to regulatory standards across various markets.

We are seeking a knowledgeable Regulatory Strategist Consultant who is keen on supporting product registration activities and collaborating with multiple departments to enhance operational efficiency. If you thrive in a compliance-focused environment and are passionate about regulatory strategies, this role may be for you.

• You support regulatory submissions (CTD, BLA, NDA) by informing site colleagues of regulatory requirements and authoring the necessary documentation.
• You liaise with regulatory colleagues to communicate and resolve potential issues that may arise during the submission process.
• You collaborate with cross-functional teams and stakeholders to ensure high-quality CMC submissions and compliance across Pfizer's portfolio.
• You manage timely responses to Board of Health requests related to lifecycle submissions in your areas of responsibility.
• You assess post-approval changes at the manufacturing site and prepare the impacted sections of the dossier for regulatory variations.
• You contribute to project completion, manage your time effectively, and develop plans to support operational goals within a team environment.
• You utilize your scientific knowledge and analytical skills to produce clear and concise regulatory documentation.