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Head Regulatory Affairs Alpine
Requisition ID: 1805622665W
‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Janssen is one of the world’s leading research-based pharmaceutical companies. For our Alpine Cluster we are recruiting a
Head Regulatory Affairs
- He/she will ensure an efficient cooperation with all Regulatory Affairs colleagues - optimal internal and external communications and alignment with the EMEA regional Regulatory Affairs (GRA) organization
- Provide relevant regulatory intelligence to other company departments, e.g. Cluster Value Team (CVTs).
Management of the Regulatory Affairs (RA) Department
- Ensure marketing authorizations and updates are in line with Regulatory Affairs requirements
- Prioritize Regulatory Affairs objectives and projects to best meet the needs of the Local Operating Company
- Ensure and promote strategic role and partnership of the RA though the core role of TA Experts at the CVTs
- Align LOC Regulatory Affairs goals and objectives and ensure implementation of the EMEA/GRA strategic functional objectives
- Set-up budget and its priorities and follow-up on expenditures
People leader of the Regulatory Affairs Team:
- Ensure direct reports receive appropriate training in the RA environment and functional skills. Encourage appropriate training and development
- Set clear performance standards, provide feedback and coaching, and hold team members accountable for key deliverables
- Conduct annual performance reviews with direct reports to help support the creation of a diverse, high performing RA organization
- Provide leadership support to team members and act as a coach to the members of the RA team. Accountable for talent- and career development of team-members
Management of the external regulatory environment:
- Oversight and engage External lead in building and sustaining positive relationships with the local health authorities and ensuring that External lead represents the company in regulatory trade association in order to lead and influence the environment changes and evolution
- Ensure a high level of regulatory professionalism, which allows high quality local interaction with HAs, at product- and non-product level
- Assess the impact of the legislation changes on the business and ensure organisation readiness to address them proactively
Contribution to the GRA organization:
- Support and ensure adequate contribution of the RA team to GRA initiatives
- Work with Compliance to implement processes, standards and training that ensure a continuous high regulatory compliance level and a constant status of “inspection readiness”.
- With RSS, ensure that systems are in place to track MAH obligations, queries etc.
- 8 or more years of experience in RA, at least 3 years experience in TA Expert or External lead role, including proven experience with people management.
- Advanced German and English skills
- Knowledge of regulatory IT systems (document management, planning, databases….)
- Big picture view of the regulatory role in the pharmaceutical industry
- Able to analyze (complex) information and situations and to formulate clear advises
- Very strong interpersonal and communication skills; able to influence without authority.
- Strong project management, problem solving and negotiating skills
- Able to make independent decisions
- Multitasking, accurate and conscientious
Have we picked your interest? Please send your online application today!
Janssen-Cilag Switzerland (7325)