Regulatory Submission Project Manager

The Regulatory Submission Project Manager role focuses on delivering projects that enhance value for patients through strategic planning, execution, and closure.

The Regulatory Submission Project Manager Skill set requires using standard project management tools such as a project charter, scope of work as well as scenario planning, risk/opportunity assessment, trade-off analyses, and partnering with stakeholders to appropriately prioritize and execute the project. These deliverables contribute to the company’s success and depending on the project, may take a long-term view.

Additionally, the Regulatory Submission Project Manager requires working knowledge of the Common Technical Document, Drug Development and Regulatory Filing procedures.

Operationally, the Regulatory Submission Project Manager will be focused on driving the submission team in alignment with the Project plan, including meeting outcomes/actions, and on adherence to agreed timelines.

The Regulatory Submission Project Manager acts as champion for Project Management techniques and processes, coaches team members in these areas and shares lessons learned for continuous improvement.

**Main responsibilities / job expectations**
- Creates and manages submission plans timelines and responsibility matrices through cross functional discussions and tracks submission deliverables to maintain the target submission date,
- Participate to the creation of a submission content plans for assigned projects and monitors progress,
- Plan, track and monitor project progress across all Submission aspects, identifying problems, forecasting risks, and proactively seeking resolutions,
- Monitor routine regulatory submissions such as those of annual reports, PSURs, DSURs and Orphan Drug annual reports etc.,
- Coordinates submission documents through review cycles and provides guidance to cross-functional groups uploading submission documents to the regulatory submission document management system,
- Coordinates sub-team meetings for major and routine submissions aligned with the GRL and submission leads,
- Identifies potential issues that could impact the target submission date and leads discussions to reach consensus around a solution,
- Manges overall completeness of scheduled submissions and coordinates with the Publishing Lead on submission timeliness and documents status,
- Manages Health Authority requests and ensure responses are submitted within the requested agency timeline while keeping relevant stakeholders in the loop,
- Involved in regulatory submission process improvements activities and establishing repeatable processes utilizing key technologies, tools and processes.

EHS responsibilities:

- Respect and enforce applicable EHS regulations and procedures.
- Promote EHS dynamics within teams for the proper functioning of the EHS management system
- Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees
- Ensure the completion of mandatory EHS training by his collaborator

**Knowledge, abilities & experience**

Education / Certifications:

- Advanced degree in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences)

**Experience**:

- Significant experience in the pharmaceutical industry, including minimum 5-7 years in Regulatory Affairs with a strong focus on regulatory submission management (project management) experience
- Strong experience in leading submission processes and CTD filings on an international level
- Strong experience of drug development and managing complex products/projects at international level
- Strong multi-cultural awareness and sensitivity
- Excellent organizational & management skills
- Strong Project management experience
- Prior Lead Role on complex submission or excellence projects
- A good understanding of the drug development stages and strategy

Languages:

- Fluent English

**Key Technical Competencies Required**

**QUALIFICATIONS**:

- Excellent written and oral communication skills and capable to deliver key communication with clarity and impact and strong presentation skills
- Strong project management skills. Able to develop and implement short to long-term plans or delivery of small to large scale projects.
- Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions.
- Excellent interpersonal and negotiation skills with an ability to build networks within Ipsen and use them to secure appropriate support and outcome for a project.
- Strong ability to identify issues in advance and seeking necessary input and support to resolve then. Ability to derive creative solutions to regulatory problems,
- Recognizes and highlights potential long-term issues for projects.
- In-depth understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a