Borcelle Pharma is a growing pharmaceutical and life sciences company committed to advancing healthcare innovation through research, clinical development, and patient-centered solutions. The company offers professionals the opportunity to work in a collaborative and dynamic environment focused on scientific excellence, regulatory standards, and improving patient outcomes across the healthcare ecosystem.

The Senior Regulatory Affairs Specialist is responsible for managing and executing regulatory strategies to support product registrations, lifecycle management activities, and regulatory compliance across local, regional, or global markets within the pharmaceutical, biotechnology, medical device, or healthcare industry. The role involves preparing, reviewing, and submitting regulatory dossiers for new product registrations, variations, renewals, and post-approval changes while ensuring compliance with applicable health authority regulations and industry standards. The candidate will serve as a key regulatory resource for cross-functional teams, providing guidance on regulatory requirements, submission strategies, labeling compliance, and product development activities to support business objectives and market expansion initiatives.

The successful candidate will collaborate closely with departments such as Quality Assurance, Clinical Operations, Medical Affairs, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial teams to ensure timely regulatory approvals and effective product lifecycle management. Responsibilities may include leading regulatory submissions, managing communications with health authorities, reviewing technical documentation, supporting audits and inspections, monitoring changes in global regulatory requirements, and mentoring junior regulatory team members. The role may also involve participation in regional or global regulatory projects, regulatory intelligence activities, and process improvement initiatives to strengthen compliance and operational efficiency. The ideal candidate should possess strong analytical, project management, and stakeholder management skills, with prior experience handling complex regulatory submissions and working within highly regulated healthcare environments.

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