Senior Publishing Manager - Global Regulatory Operations
A large biotech is in search for a Senior Publishing Manager to coordinate the publishing within Global Regulatory Operations. You will be expected to design and execute high quality submission plans, act as the primary contact for projects and submissions teams while also providing technical expertise to cross-functional teams.
- Monitors the development of new regulatory requirements or guidance's, and provides advice to Global Regulatory Operations and product teams of the impact on the business;
- Contributes to development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities;
- Participates in selection and implementation of electronic Regulatory Document Management systems (including Part 11 compliance);
- Responsible for ensuring compliant and timely archiving of all regulatory submissions and correspondences for products;
- Assists the Submission Operations Lead in assessing impact of standards and requirements with a regional impact to existing and new systems;
- Assists leadership in advising company on optimal submission strategy. Assists in actively engaging external and internal initiatives;
- Works with GRO leadership to oversee strategic implementation of outsourcing services, when needed;
- Ensures SOP adherence, application of best practices, oversight of contractors and CROs, and customer/stakeholder interactions, and overall vendor management activities;
- Oversees the activities related to obtaining CPPs and other similar certificates;
- Responsible for management of the cross-functional global submission teams in the delivery of compliant submission components according to agreed standards, requirements, timelines and processes. This includes planning and presenting at project 'kick-off' meetings and preparing appropriate materials to facilitate team discussion, timeline mapping and submission strategy;
- Participates and shares lessons learned sessions to encourage process improvement and efficiencies within and across submission project teams;
- Negotiates and agrees on realistic dates for document handoffs in collaboration with the authors, regulatory submission project manager and publishers;
- In collaboration with the regulatory lead, manages the development and maintenance of a global submission content map, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval and publishing
- May support a dual role function as a Regulatory Submission Project Manager, see additional role responsibilities for an RSPM.
Skills and Requirements
- A minimum of 7 years of experience in regulatory affairs/operations within the pharmaceutical industry;
- Strong verbal and written communication and presentation skills. A superb training skill is a plus.
- Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams;
- Self-motivated and results-oriented with high energy drive to mentor junior members of the group;
- Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.);
- Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable;
- Expert knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools. Solid experience and knowledge of SharePoint technology is desired
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.