This Regulatory Project Manager job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in Beerse, Belgium. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide. The Regulatory Project Manager will be a core member of Global Regulatory Team (GRT) and the Program Management Team (PMT) for a compound where appropriate and will be a member of other business teams as assigned by the Head or People Managers.
The RPM is accountable to both the Global Regulatory Leader and the PMO leadership for planning, executing, controlling, and reporting the functional regulatory plan in line with Regulatory and Compound strategy. As a core member of the Global Regulatory Team the RPM provides cross-functional operational and program management leadership for the development of therapeutic products or non-interventional healthcare platforms in a global, matrix organization, from entry to late development through complete of major lifecycle extensions.
- The RPM works in partnership with the GRL to achieve the following results:
- Translate the CDT/GRT strategy to functional plans with goals & objectives in alignment with organizational objectives. Contribute to and coordinate regulatory strategy updates over time; provide context and history to new GRT members/stakeholders. Utilize and embed GRA processes and tools to manage team and facilitate work.
- Drive the GRT to meet or exceed those goals by providing superior global cross-functional operational leadership and management in a matrix organization, facilitating issue identification and resolution, problem-solving, risk management, contingency planning and decision-making-the RPM challenges the status quo and leads innovation.
- Manage the GRT in a manner that fosters and maintains a high-performance team culture; at the direction of the GRL. As delegated, chair GRT, GST, RRT meetings and lead operations for regulatory such as management of WW submissions, preparations for Health Authority meetings and other regulatory deliverables.
- In collaboration with the GRT develops functional plans aligned with compound strategy. Integrates WW submission strategy, maps pre-and post-submission activities, manages delivery of regulatory components of submissions. Incorporates EMAX as appropriate
- Facilitates the development of indication specific submission content. Optimizes the impact of the Global Submission Strategy Teams by ensuring the development and tracking of key messages. Utilizes GRA tools to manage this.
- Challenge the team to be innovative, make it safe to try new approaches and take prudent risks. Coach the team to bounce back quickly from disappointments and learn from mistakes. Drive process improvements across the functions. Self-accountable for the GRTs performance.
Skills and Requirements:
- A minimum of a Bachelor’s degree is required.
- Post-graduate degree in Regulatory related field is highly preferred.
- Post graduate degree in life sciences, engineering, or business management is preferred.
- Regulatory certification (RAC) is preferred
- Professional project management certification and/or diploma is preferred.
- 5 years of relevant experience including at least 5 years in regulatory in (bio)pharmaceutical R&D.
- Knowledge of regulations, guidelines and regulatory requirements is required
- Prior experience as a member of a cross-functional team is required.
- Experience in planning and management of global regulatory submissions (e.g. NDA, MAA, and lifecycle documents etc.) is highly preferred.
- Demonstrated understanding of Global Regulatory Affairs processes, both pre- and post-marketing is highly preferred
- Strong knowledge and comfort with MS Project or other management tools.
- Successful experience managing or leading global and/or virtual teams is preferred, especially if done within a matrix organization.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.