You will need to login before you can apply for a job.
Senior Manager/Associate Director, Regulatory Asset Oversight
Sector: Legal, Technology
Role: Senior Manager
Contract Type: Permanent
Hours: Full Time
Site Name: UK - London - New Oxford Street
Posted Date: Dec 13 2024
The Senior Manager/Associate Director, Regulatory Asset Oversight will partner with the GRL and Regulatory Matrix Teams (RMT) and Early/Medicine Development Teams to provide over-arching project management support to active Rx and Vx projects across the lifecycle of the asset.
As Senior Manager/Associate Director, Regulatory Asset Oversight you will create and manage integrated regulatory plans, and ensure the team is on track to deliver per the Regulatory strategy. You will be responsible for ensuring a consistent approach to Regulatory Asset oversight activities within and across project teams which best serve R&D Pipeline and key Established Products goals and ultimately the Patient.
Collaborates and networks across the R&D matrix to ensure that project management and submission oversight activities are agreed and aligned to efficiently support R&D portfolio aspirations. Coordinates with Submission Delivery Excellence colleagues on the operational execution of the strategy.
This role requires leadership within and across enterprise matrix teams including GRA (both central and at the Local Operating Company level), GRO, and contributing departments (e.g. Clinical Operations, Data Management, Stats and Programming) as needed to facilitate submission delivery expectations.
The job holder may be responsible for managing other Regulatory Asset Oversight Managers.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
In this role you will
* Develop and maintain a holistic view of the global regulatory integrated plan at the asset level in collaboration with the GRL and RMT.
* Drive the execution of agreed plans, performing scenario planning, impact analyses, and risk mitigation.
* Assist RMTs and GRLs with submission delivery strategies that align with R&D objectives.
* Implement a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.
* Proactively partner as a Single Point of Contact with RMT, Submission Coordination, and Publishing colleagues.
* Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information for RMTs.
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Degree in a biological, healthcare, or scientific discipline or extensive experience within the drug development environment.
* Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
* Strong project management expertise in the pharmaceutical industry or in a regulatory environment.
* Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval.
* Experience with project management and resource management systems, tools, & reporting features.
* Ability to effectively lead multidisciplinary team meetings.
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred:
* Training in project management skills/tools.
* Excellent written and verbal communication skills.
* Ability to effectively interact at different levels in the regulatory organisation.
* Ability to gain consensus on a way forward.
* Ability to proactively identify and mitigate risks and potential bottlenecks.
Closing Date for Applications: 10th Jan 2025 (COB)
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
As an Equal Opportunity Employer, we are open to all talent.
We believe in an agile working culture for all our roles.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us.
#J-18808-Ljbffr