Senior Regulatory Portfolio Manager
Salary: £45.60 Per Hour PAYE
Contract Length: 12 month contract
Working Hours: 35 hours per week
Location: Uxbridge based – 2-3 days per week onsite
CPL have partnered up with a well renowned Biopharmaceutical company to find an experienced individual within Regulatory Affairs. This company participates in the development and delivery of innovative medicines of serious and life threatening diseases. A successful applicant would be working with Regulatory Leads and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets. In this role you would report directly to a Group Leader in Regulatory Portfolio Management.
Responsibilities:
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
Qualifications/Skillset & Experience required:
- 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
If you feel this role would be a good fit or are interested in finding out more details about the role, please feel free to contact me via email at [email protected]