Regulatory Affairs Project Manager

07 Jan 2019
07 Feb 2019

Specific activities may include but not limited to:

Prepare material for and lead Workstream Kick-Off meeting, dashboard maintenance

Attend core transition team meetings to provide RA PS status updates, issue reports, etc and to communicate relevant cross functional updates back to RA PS workstream team

Collect and collate workstream team ‘sub-lead’ sub-milestone dashboards on regular basis

Maintain overall PS RA workstream risk/issue/action log and follow up with workstream ‘sub-leads’ for appropriate applicable resolution

Coordinate and engage in stakeholder communication

Engage Company Buddy in appropriate issue escalation

Provide guidance and direction to the Workstream team, as well as SUPPLIER delivery team including Green Light Lead, Regulatory Affairs team, Pharmacovigilance Agreement Lead, Information Transfer team and other team members assigned, and continue status reporting upon transition

Maintain all project documentation in ERA Box, including documentation to substantiate mutual acceptance of milestone status with external workstream lead counterpart

Be proactive in ensuring the successful completion of the PS and RA activities required for the asset transfer to the project milestone plan

Prepare tracking tool and other methods for status reporting

Report on progress for Workstream to project milestones, as well as insure sub-milestone reporting for Green Light process, Information Transfer, Regulatory Affairs activities and other activities as assigned

Review PVA for consistency with milestone plan

Report on progress of PV Agreement completion

Plan, manage and lead PV Agreement team meetings, if delegated by PVA lead

Collect and collate comments and decisions on regular basis

Be proactive in ensuring the successful completion of the PV Agreement

Train functional team for Data Transfer activities and system usage (ANGEL transfer, LSA training, Box training etc)

Maintain inventory of information exchange with support from the data/information reviewer and RDI/ISSA/AIM teams


Specific Skills required:

Highly organized, proactive, and detail oriented

Experienced communicator and facilitator

Effective time manager

Proficient in standard business productivity tools (e.g. Microsoft Office package)

Strong understanding of template standard language for PV Agreement

Working knowledge of Regulatory and Patient Safety legislation, worldwide, and standard documentation/document types including understanding of GDP, GPV

Strong team building capabilities

Good organization and problem-solving skills

Ability to establish and maintain effective working relationships with a diverse set of Global internal/external cross functional co-workers, managers and clients


2 or more years in a Project Management role leading similar sized efforts

6 or more years working in a Regulatory (Regulatory Affairs and Patient Safety/Pharmacovigilance) role including assisting in the developing regulatory submission documents and coordinating delivery to submission plans

4 or more years working in a Regulatory or Patient Safety role with exposure to (reviewing/authoring) PVAs

Experience in regulatory requirements for asset transfers

Knowledgeable in worldwide RA and PV Regulations, ICH guidance

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