Director of Regulatory Affairs

Invenia is working with a growing manufacturer of scientific instrumentation to hire a Director of Regulatory Affairs.The company manufactures cell biology tools to advance workflows in the cell & gene therapy and bioproduction markets. They have an has an excellent culture and truly value their employees.The role:The Director of Regulatory Affairs will be responsible for leading the regulatory function, creating and executing compliance strategies to meet both business needs and regulatory standards. This role involves maintaining current regulatory filings, interpreting and communicating requirements, and ensuring compliance to secure governmental approvals.Responsibilities include: Interpret and apply global regulations to support complianceMaintain and update Master Files internationallyDevelop regulatory strategies for efficient product developmentCollaborate with Legal, Quality, Manufacturing, and other teams for timely submissionsSupport project teams in addressing regulatory risks and strategizing solutionsEstablish and implement regulatory processes and best practicesLead communications with global regulatory authorities to resolve issues and secure approvalsAssess and adapt strategies based on regulatory changesEnsure compliance with health, safety, and environmental policiesWhat we are looking for:PhD in a science related subject is preferred8+ years in regulatory roles, ideally in biologics and cell/gene therapyKnowledge of global regulatory standards, especially FDA processesExperience in global DMF filings and regulatory complianceStrong problem-solving skills with a focus on risk-based solutionsExcellent written and verbal communication; ability to simplify complex requirementsBusiness acumen and cross-functional team experienceIn-depth knowledge of industry trends and regulatory changesProven relationship-building and influence skillsIf you have the experience for this role please apply to find out more

Created: 2024-11-09