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 knowledgeableRegulatory Strategist Consultantwho 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.What are we looking for?You hold a Master's degree in Life Sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer).You have a minimum of 3 years of experience in the pharmaceutical sector, or equivalent experience through a PhD, with a focus on regulatory activities (authoring CTD, BLA) and quality assurance.You possess scientific knowledge and analytical skills relevant to technical writing for regulatory documentation.You have knowledge of drug regulations and guidance from leading regulatory agencies (EMA, FDA).You are an excellent communicator, both verbally and in writing, and possess good negotiation and influencing skills.You are dynamic, flexible, enthusiastic, and eager to learn.You can work effectively under minimal supervision and within a team.You are fluent in written and spoken English .