Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
PURPOSE OF THE FUNCTION
In partnership with the Regulatory Leads, the RPM drives submission projects
forward through the translation of regulatory strategy to executable plans and
coordination of cross-functional team efforts. The RPM utilizes in-depth knowledge of regulatory submission requirements, eCTD structure and associated planning software to create and maintain a detailed integrated Submission Plan that captures the list of dossier content, key activities, and timelines.
The RPM partners with the Indication Development Team (IDT), Regulatory Lead, the Project Manager (PM) and the asset Project Lead (PL) to ensure alignment with the regulatory prerequisites and overall product development plan. The RPM leads in the facilitation of submission team execution of operational plan, implementing Project Management techniques, processes and tools, as needed.
REPORTING LINE
The RPM reports to the RPM Lead with a dotted line accountability to the Head of Regulatory Affairs.
ROLES AND RESPONSIBILITIES
• The RPM partners with PM and Regulatory Leads as applicable and consults other Submission Team members to create an integrated and dynamic operational regulatory submission plan in support of projected global regulatory approval for assigned asset(s) in targeted regions, and therapeutic indications and/or presentations per corporate strategy;
• Scenario planning taking into account all submission activities that rely on resources needed for assigned submission plans;
• Creates visuals, reports to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders; anticipates delays and mitigates impact to timelines ;
• Ensures submission team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activitiesand meets target submission dates;
• Enables function leads to ensure that all documents are prepared with global
Regulatory/ Health Authority quality standards;
• Leads submission planning discussions incl., setting agendas, minutes and follow up on key actions with stakeholders;
• Works with functional teams to identify ways to optimize and accelerate submissiontimelines;
Partners with PMs to ensure submission project plan and cross-functional project plans are aligned and optimized;
• Manages submission planning meetings, including agenda preparation, minutetaking, communication of decisions; tracking and resolution of action items;
• Translates post-submission requirement into an executable post-submission plan;
• Identifies any issues, risks, or impact due to changes in strategy and/or timelines throughout the submission process;
• Identifies key learnings & best practices and shares lessons learned across programs in order to refine and improve submission processes;
• Contributes to the development of the Project Community Centre to share best practices and tools across Project Management community;
• Leads and/or participates in cross-functional and functional workstreams/initiatives
SKILLS AND COMPETENCIES
• Strong leadership skills;
• Strong communication and collaboration skills;
• Strong interpersonal skills;
• Strong project management skills (PMP certification is an advantage);
• Ability to respond positively to continuous change and to bring creative solutions to challenges.
EDUCATION, EXPERIENCE AND QUALIFICATIONS
• Requires a Master’s degree (or foreign equivalent) in Regulatory Affairs,
Pharmaceutical Studies or a directly related biotechnology field with at least 2 years of Regulatory Project Management experience, including experience managing global submissions;
• Experience must include three (3) years of experience in the following (experience may be gained concurrently):
o Drug development experience within the distinct phases of development, in
different disease areas;
o One (1) year of experience in the following (experience may be gained
concurrently):
Program Management experience within a regulated Pharmaceutical
or Biotech environment;
Creating and maintaining Global submission plans to be compliant
with regulatory timelines and capturing eCTD content and associated
activities;
Pharma R&D;
Drug development project management using MSP; experience with
One-pager Pro, Planisware and PowerBI is a plus;
Experience in development of biologicals and rare diseases
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