Munich, Bavaria, Germany
.
- Leading the ePIL project, ensuring compliance with EU and local regulatory requirements - Coordinating digital labeling activities across multiple product portfolios - Reviewing and approving artwork and labeling content for accuracy and consistency - Making regulatory submissions related to labeling updates and variations - Collaborating with global and local cross-functional teams to align digital labeling strategies - Contributing to process improvements in digital labeling workflows, increasing efficiency and compliance
Responsibilities: - Assist in the preparation, review, and organization of regulatory documents such as submissions to regulatory agencies, reports, and correspondence. - Conduct research on regulations, guidelines, and best practices relevant to the company's products or industry. - Support the preparation and submission of regulatory filings, including new product applications, amendments, and periodic reports. - Assist in communication with regulatory agencies, including responding to inquiries, requests for information, and notifications. - Ensure that regulatory documents and processes adhere to company standards and regulatory requirements. - Help maintain regulatory compliance tracking systems to monitor the status of regulatory submissions and approvals. - Stay informed about changes in regulations, guidelines, and industry trends that may impact the company's products or regulatory strategy. - Maintain regulatory documentation, including regulatory files, databases, and archives. - Participate in training sessions to enhance understanding of regulatory requirements and processes. - Contribute to special projects as assigned by regulatory affairs managers, which may involve process improvements, regulatory strategy development, or other initiatives. - Organise and moderate department meetings.
Contracted to Johnson & Johnson