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.
Regulatory Affairs Professional (m/f)
Location: Zagreb, Croatia
Full-time limited contract
- Ensure an efficient cooperation with Regulatory Affairs colleagues in the region of CEE and EMEA, optimal internal and external communications and alignment with the EMEA regional Regulatory Affairs (GRA) organization
- Provide relevant regulatory intelligence to other company departments, incl. LOC MAF, commercial teams.
- Lead contacts with regulatory external stakeholders and regulations, in line with EMEA strategy, maximizing the possibilities of success for market access, reimbursement and lifecycle maintenance of Janssen products.
- Overarching and strategic discussions with health authorities and trade associations
- Management of the Regulatory Affairs:
- 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
- Align LOC Regulatory Affairs goals and objectives and ensure implementation of the EMEA/GRA strategic functional objectives
- Ensure all obligations related to the new MAAs and life cycle management activities are managed according to the timelines and requirements, cooperate closely with ERMC
- 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 LOC RA, enabling LOC commercial organization to optimize the strategy and LOC RA to shape the RA environment and take action where needed
- Be fully up to date with local and regional changes in the Regulatory environment
- Work with Compliance Lead CEE 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 updated on tracking 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
- Good interpersonal and communication skills; able to influence without authority
- Project management, problem solving and negotiating skills
- Good in communication to authorities: understanding of regulatory legislative process and impact; Persuading, influencing and negotiation skills
- Analytical and strategic thinking
- Solid RA legislation knowledge
- Able to make decision
- Apart from a local language, very good knowledge of English, verbal and written
- Multitasking, accurate and conscientious
- An opportunity to be part of a global market leader
- A dynamic and inspiring working environment
- Many opportunities to work on challenging projects and assignments
- Possibilities for further personal as well as professional development
- Motivating financial remuneration
- Other employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your structured professional CV and short cover letter in English through the Apply for the position button below. You will be redirected to our career page and guided through the application.