Johnson & Johnson
Senior Regulatory Affairs Manager - UK - Permanent
Senior Regulatory Affairs Manager - UK (PERMANENT ROLE)
Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
Leads Regulatory to ensure timely approvals and maintenance of legally marketed products to meet company objectives through the execution of sound Regulatory strategies/practices and focused interactions with governmental agencies and business partners.
Duties and Responsibilities:
- Supports creation and maintenance of Regulatory documentation/submissions across EU, USA and ROW inclusive of NPD and Life Cycle Management activities.
- Provides recommendations based on regulatory policies, standards and expectations to ensure a fair balance of business and regulatory risk.
- Provides a strategy for rapid and timely approval for new products introductions and regulatory support for marketed products.
- Continuously drives regulatory activities in strategic markets to ensure timely product approvals and actively support improvement initiatives.
- Continuously monitors the regulatory environment and is accountable for implementing strategic systems and process changes to anticipate and meet the challenges of evolving requirements.
- Supports the development and implements global regulatory strategies and plans in support of functional imperatives for Joint Reconstruction and CMW, for changes to manufacturing sites, processes, global product transfers and legal manufacturer transfers to DePuy (Ireland).
- Partners with business leaders in developing strategies ensuring clear visibility to risks and early identification of regulatory challenges.
- Partners with the Regulatory across Joints to promote efficiency and ensure consistent processes on a worldwide basis.
- Liaise with other EMEA MD&D Regulatory organizations for DePuy Synthes.
- Partners with QA to assist in the management of external inspections and any follow ups, and ensures that business is in a constant state of readiness for notified bodies, competent authorities, and other government agencies conducting regulatory audits or inspections.
- Supports vigilance activities and attendance at PRA, HHE and QRB’s meetings as appropriate.
- Supports planning project priorities and directing resources within the joint Hip and CMW platform to deliver business imperatives and maintain regulatory compliance.
- Acts as an expert consultant to Regulatory staff and other functional groups on regulatory matters
- Established accountability for maintaining budget and resource planning information and KPI.
Professional Experience Required:
- Minimum of 10 years relevant, health regulated industry regulatory affairs experience is required.
- 8 -10 years of experience is required in Medical Devices, preferably with similar products (Class 2 or 3A)
- Knowledge of FDA and EU regulations required
- Demonstrated track record of formulating and executing global regulatory strategies in support of strategic business objectives is required.
- Minimum of a B.A./B.S. is required.
- Ability to create a high performing team/culture by providing strong motivational, functional leadership with a focus on team and individual development, coaching and mentoring – leads and develops regulatory staff to become future leaders.
- Demonstrated effective change leadership and change management skills are required.
- Professional attitude and service orientation; superb teammate
This is a fantastic opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson.
If you are interested in this role please apply now, or for more information contact Tabitha.Crabtree@randstadsourceright.co.uk