Janssen - Regulatory Affairs Specialist- expert on Value Optimizers

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. We have 40,000 people around the world who show up every day to achieve the unimaginable. This work requires heart, science, and ingenuity. We never stop imagining a future where the most challenging diseases are a thing of the past. An exciting opportunity has arisen to join the EMEA (Europe/Middle East/Africa) Regulatory Affairs Established Products Therapeutic Area team at Janssen. This position as a Regulatory Affairs Professional, Expert on Value Optimizers (VO), includes the responsibility for a diverse range of established products and activities within the Regulatory Affairs function in support of the Italian local operating company. The position reports to the Team Leader of Regulatory Affairs Experts on Value Optimizers and has a dotted line to the Italian Regulatory Affairs Head. The Position is based in Italy, precisely in Cologno Monzese (MI). Objectives of the Role Keep an overview of all regulatory-related activities for the assigned products, such as managing life cycle activities from variations to marketing authorization transfers and withdrawals as well as supervising the implementation of procedures and compliance. Perform all required product tasks, following plan and updates from Regulatory head office, enabling efficient label implementation and maintenance as well as review of promotional material. Interact and collaborate with all relevant internal functions and represent Regulatory Affairs in the Italian cross-functional Value Teams for established products and provide input to the price and reimbursement activities. Ensure that, where any local issues are identified as potentially impacting regulatory strategy, these are highlighted to Regional and Italian RA management to ensure that the regulatory strategy can be implemented efficiently. Establish efficient compliance to local, regional, and Janssen regulations, to minimize risk for the patients and Janssen business. What you will need to succeed We are looking for a multifaceted and result-oriented professional willing to work with passion, energy, and dedication to the work. You work independently in a virtual environment with the capability to work under your own initiative, self-starting and proactive, while at the same time being an excellent teammate in collaborations. You are flexible, have a "can-do" attitude and enjoy contributing to improvement of processes and challenge the status quo. You listen and build an atmosphere of trust and mutual respect. You have excellent verbal and written communication skills, strong attention to detail, and good interpersonal skills. You can easily see the big picture and have the ability to work with local site teams, regional partners, and senior leaders. You have a strong performance orientation with a passion for delivering quality. Qualifications Qualifications University degree – in scientific fields (pharmacy, biology, chemistry etc.) Around 3 - 5 years of experience of Regulatory Affairs in the Pharmaceutical Industry; In depth knowledge of Italian regulations & legislation, good knowledge of regulatory guidelines and practices in EMEA region; Native speaker level in Italian (C2) and excellent knowledge of English (B2 and above); Project management skills, ability to prioritize and sense of urgency; Strong interpersonal, communication, teamwork and negotiation skills; Ability to work in a remote matrix organization, act independently and as part of multiple teams; Ability to work under strict timelines, combined with flexible work situations when required; Ability to adapt to new systems and procedures; For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Italy are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Primary Location Italy-Lombardia-Cologno Monzese- Organization Janssen-Cilag S.p.A. (7175) Job Function Regulatory Affairs Requisition ID 2206036343W