Regulatory Affairs Portfolio Manager
Posted 3 days ago
- Uxbridge, Greater London
- Any
- External
- Expires In 3 months
Job Title:
Regulatory Portfolio Manager
Job Type:
8-month contract PAYE (Inside IR35)
Location:
Uxbridge, UK – Hybrid/Remote
Rate:
Up to £45.60 per hour PAYE
An exciting opportunity to join a leading pharmaceutical business on a contract basis.
The Regulatory Portfolio Manager partners with Regulatory Leads and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets. The role reports directly to a Group Leader in Regulatory Portfolio Management.
Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s):
Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision-making
Develop and maintain the asset’s global regulatory book of work and Global Submission Plan including:
Tracking key regulatory milestones as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc.
Liaise cross-functionally to generate periodic internal milestone reports
Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s priorities
Communicate status and timeline changes
Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
Review prior health authority queries to guide response development
Represent the Global Regulatory Lead in team as needed
Partner with the US Regulatory Lead to:
Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
Support and co-ordinate preparations for FDA meetings
Provide additional support e.g., precedent analysis
Regulatory Portfolio Managers may also:
Lead or represent RPM on GRS and enterprise process initiatives to drive a culture of continuous improvement and operational excellence
Engages with customers to enhance RPM support
Degree or equivalent in healthcare related field
Direct regulatory experience with developing knowledge of US and/or EU procedures
Ability to work independently and at pace in a global matrix environment and effectively prioritize
Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan
Continuous improvement mindset
Strategic problem solver
Good communication and negotiation skills
Good interpersonal skills
Requirements:
MUST have a suitable degree in life sciences
3/5 years of experience in Regulatory Affairs
Strong Regulatory Strategy experience
Ideally someone who has worked on both pre and post approval
Full right to work in the UK
For more information please contact #####
Regulatory Portfolio Manager
Job Type:
8-month contract PAYE (Inside IR35)
Location:
Uxbridge, UK – Hybrid/Remote
Rate:
Up to £45.60 per hour PAYE
An exciting opportunity to join a leading pharmaceutical business on a contract basis.
The Regulatory Portfolio Manager partners with Regulatory Leads and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets. The role reports directly to a Group Leader in Regulatory Portfolio Management.
Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s):
Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision-making
Develop and maintain the asset’s global regulatory book of work and Global Submission Plan including:
Tracking key regulatory milestones as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc.
Liaise cross-functionally to generate periodic internal milestone reports
Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s priorities
Communicate status and timeline changes
Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
Review prior health authority queries to guide response development
Represent the Global Regulatory Lead in team as needed
Partner with the US Regulatory Lead to:
Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
Support and co-ordinate preparations for FDA meetings
Provide additional support e.g., precedent analysis
Regulatory Portfolio Managers may also:
Lead or represent RPM on GRS and enterprise process initiatives to drive a culture of continuous improvement and operational excellence
Engages with customers to enhance RPM support
Degree or equivalent in healthcare related field
Direct regulatory experience with developing knowledge of US and/or EU procedures
Ability to work independently and at pace in a global matrix environment and effectively prioritize
Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan
Continuous improvement mindset
Strategic problem solver
Good communication and negotiation skills
Good interpersonal skills
Requirements:
MUST have a suitable degree in life sciences
3/5 years of experience in Regulatory Affairs
Strong Regulatory Strategy experience
Ideally someone who has worked on both pre and post approval
Full right to work in the UK
For more information please contact #####