Job Description

Job purpose: The Regulatory Affairs Operations (RegOps) Lead is responsible for overseeing Regulatory Operations activities and strategic initiatives in support of pre- and post approval filing as well as ongoing document maintenance efforts within the OTC division. The position requires participation in and supervision of formatting, publishing, compilation and submission of all regulatory documentation to national and international regulatory authorities. This individual will be a key member of multi disciplinary project teams, maintain submission-planning timelines for assigned submissions, and implement submission strategies together with Regulatory Affairs Personnel. The RegOps Lead will oversee activities for assigned projects and will also be responsible for supporting the development of reports or activities to implement new technology solutions in support of the Regulator Affairs Systems division. Key Job Outputs Responsible for overseeing and guiding the operations of teams managing the creation, assembly, and publishing of electronic submissions, including New Product Applications and Life Cycle Amendments. Represents Regulatory Operations on project teams for matters relating to electronic submissions, driving timelines and deliverables related to submission documents. Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities, ICH and internal working practices. Liaise with functional source areas (clinical, quality, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports and/or leads the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities to the RA Systems Department. As needed, trains colleagues and project teams. Ensure alignment of personal and company values
Qualifications/experience Pharmacy Bachelors degree or equivalent in Life Sciences or technology-related discipline with minimum 2 years Regulatory Operations experience required. OR Grade 12 with at least 5 years pharmaceutical industry experience, with prior Regulatory Operations experience required. Experience leading the management of projects/timelines and collaborating with team members Expertise in the use of a document management, eCTD format and regulatory submission requirements and eCTD publishing systems Advanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems Previous experience developing work instructions and generating SOPs that are consistent with health authority requirements and company business practices Proven ability to manage, streamline and collaborate to improve document preparation and management systems

Skills Required