Johnson & Johnson Careers
Head of Regulatory Affairs
Requisition ID: 1905763317W
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
Janssen, part of Johnson & Johnson Family of Companies is now looking for an experienced Head of Regulatory Affairs:
Head of Regulatory Affairs
She/He 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. Provides relevant regulatory intelligence to other company departments. To have a strong leading influence on main regulatory external stakeholders and regulations, in line with regional EMEA strategy, maximizing the possibilities of success for market access, reimbursement and lifecycle maintenance of Janssen products. All overarching and strategic discussions with health authorities and trade association to shape the regulatory environment
- 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 Regulatory Affairs
- Align LOC Regulatory Affairs goals and objectives and ensure implementation of the
- Regional strategic functional objectives
- Set-up budget and its priorities and follow-up on expenditures
- To be 100% up-to-date with all relevant developments in the regulatory environment and translate these developments into relevant actions for the local commercial and Regulatory Affairs
- Shape the external environment applying a long term strategy while focusing on and being aware of priorities and objectives Be fully up to date with local and regional changes in the Regulatory environment
- Shares updates on the Regulatory environment locally and regionally
- Work with Compliance to implement processes, standards and training that ensure a continuous high regulatory compliance level and a constant status of “inspection readiness”.
- Ensure that systems are in place to track MAH obligations, queries etc.
Skills and capabilities:
- 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
- Excellence in communication to authorities: understanding of regulatory legislative process and impact; Persuading, influencing and negotiation skills
- Analytical and strategic thinking
- Helicopter view
- Solid RA legislation knowledge
- External network builder
- Articulate personality, intuition, and willingness to influence and shape the external environment
- Able to make independent decision
- Apart from a language, very good knowledge of English, verbal and written
- Multitasking, accurate and conscientious
- Knowledge of regulatory IT systems (document management, planning, databases….)
- 8 or more years of experience in RA in Romania, at least 3 years experience in RA Head/Lead role, including proven experience with people management.
In return, we offer:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Possibilities for further personal as well as professional development.
- Work in a positive atmosphere with a highly motivated, energized team a good track level of success in business
- Many employee benefits.
JOHNSON & JOHNSON ROMANIA S.R.L. (7159)