Job
Description
Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this Regulatory Affairs Operations role could be an exciting opportunity to explore This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Advise and assist authors with the preparation of submission content and use of GSK document management systems and procedures Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with submission format Participate & Lead in the creation and implementation of publishing working practices and procedures aimed at simplifying processes and increasing quality. Deliver of complex submission packages independently, to agreed schedule and technical specification Check compliance of others work with requirements and standards Advise and assist authors with more complex or non-routine content preparation or document management procedures Support submission team review and approval procedures Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 1-6 years of relevant experience of preparing electronic regulatory submissions. Advise and assist authors with more complex or non-routine content preparation or document management procedures Excellent knowledge Chemistry, pharmacy or other related science or regulatory affairs and preferably experience with the use of complex IT tools knowledge (e.g. MS Word, MS Excel, Adobe PDF, SharePoint, Internet Explorer etc) in a large organization. Preferred Qualifications: If you have the following characteristics, it would be a plus Master s degree Excellent verbal and written communications skills Ability to work carefully under time constraints and prioritize accordingly Adaptable to fast-paced environments with changing circumstances, direction, and strategy Exposure to work within a regulated environment, ideally in drug development Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. Important notice to Employment businesses/ Agencies GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. .
