Senior Regulatory Affairs & Submissions Project Manager - Pharma
Posted on May 12, 2020 by Coopers Group GmbH
- We are looking for an experienced PM WITH experience in Regulatory Affairs & Submissions.
- The perfect candidate is an experienced project manager with drug development and regulatory knowledge.
- This person should have strong interpersonal skill as to be able to lead without direct authority. He/She will oversee complex programs and regulatory submissions projects.
- The Product Project Manager Position is dedicated to supporting Technical Regulatory Teams (TRTs) in managing programs efficiently and effectively and in executing regulatory activities.
- This role will be involved in all aspects of TRT operations, while maintaining a tight linkage to the PTR Project and Portfolio Management Group (PPM).
- The Product Project Manager is an advocate of PPM, utilizing best practice methodologies to support TRTs and portfolio managers in providing clear communications for assessment and trending of the PTR portfolio.
- This role builds effective relationships with Technical Regulatory Leads (TRLs), TRT Members, Technical Development Teams, Technical Product Teams, PPM and other program stakeholder to ensure visibility to TRT operations and cross-functional alignment of TRT strategy.
- Support TRTs and TRLs in developing TRT charters, plans, detailed schedules, deliverables lists, status updates, resource requests and program specific communications for individual programs in the regulatory product portfolio including large molecules, small molecules, devices, antibody drug conjugates.
- Be a thought partner to TRLs and team members, facilitate and drive team discussions based on high-level program knowledge.
- Provide project management support to TRTs at any stage of the drug development life cycle (ie early or late stage development, marketing authorization or post-launch marketed phases). Provide support of PTR Strategic Focus Areas and cross-organizational initiatives
- Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications.
- Partner with TRLs and teams, facilitating team interactions and mobilizing teams to deliver successfully on the agreed objectives.
- Execute project management activities to support products for global market applications and product life cycle activities.
- Support issue-specific multi-product impacting regulatory projects to ensure alignment of regulatory strategy and compliance across the Biologics and Small Molecule platforms.
- Ensure regular and meaningful project communications, including dashboards, reports and metrics, to enable timely information and analyses to key stakeholders and decision makers.
- Ensure product information flows between TRT members to ensure transparency, informed decision making, and optimal alignment of all technical regulatory deliverables.
- Maintain linkage between TRT and TDT or TPT ensuring alignment of assumptions and communications at all times.
- Facilitate regulatory program risk assessment and align with TPM and TDT processes. Develop, execute and report on risk mitigation or issue resolution activities.
- Proactively monitor timelines, submission process KPIs, critical path and resources for assigned products using appropriate tools, project management principles and practices. Monitor timeline deviations from baseline and KPIs and closely collaborate with TRLs and Submissions Leads to keep submissions on track. Assist with driving data compliance and accuracy across the organization.
- Provide support to PPM and PTR management on major departmental and cross-functional initiatives including Strategic Focus Areas (SFAs).
- Leverage and continuously improve PPM business processes and program management methodologies.
- Develop and maintain the PPM resource library (templates, tools etc.) and improve it based on use and feedback by the TRTs.
- Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed.
- Train and onboard peers and TRT members in the principles of Project Management and standardized processes for TRT operations.
- Min 8-10 years' experience in project management in pharma*
- Excellent regulatory knowledge and experience*
- Excellent understanding of drug development and CMC*
- BA/BS or MS in Scientific, Technical, Engineering or Business discipline. Advanced degree preferred*
- Prior experience with programs and portfolios in a strategic context is a plus.
- Knowledge of agile methodology is highly desired.
- Excellent interpersonal skill (communications, organizational skills and leadership mindset)