Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson Family of Companies. 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.
**Johnson&Johnson; Consumer **is the Worldwide leading Consumer Healthcare Company with the specific focus and mission to develop and market innovative OTC and consumer healthcare products and services.




**Pomezia **Plant is the biggest J&J; Consumer Production Site in the World and a point of reference in terms of innovation and quality.
Do you want to join our team?
**Johnson & Johnson** Consumer Plant in Santa Palomba (RM) is looking for a** Regulatory Affairs Specialist** to be hired with a **12 months fixed term** contract.
**1) Activities for growth of pipeline**
- Support for strategic regulatory contribution to the J&J; Italian business management that contributes to achieve business objectives
- Support for relationship with key external agencies (AIFA/MoH etc..). Manage the AIFA/MoH interface throughout the development and lifecycle of a product.
- Active role in interpretation of legislation for Italy
- Develop partnerships with local functions and EMEA Regional functions to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
- Support in resolving product quality issues in order to minimize the impact on business.
- Review, approve and submit to HA promotional material
**2) Maintenance of the products**
- Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and system (e.g.



CMC change control, product labeling etc.) are in place.
- Preparing submissions of license variations and renewals, follow up on regulatory submissions and activities with HUB marketing, Brand Activation Team (BAT) and supply chain in order to avoid delay and to identify obstacles that may effect on approvals timing
- Prepare or request the preparation of additional information or responses as requested by regulatory agencies.
- Reviewing and approving the product SPC, labeling and packaging changes of company products according to J&J; SOP and AIFA requests to ensure compliance with local markets requirements and J&J; Standards.
- Support the LSO when regulatory contribute is required (PSUR, CFI, CCDS)
- Maintenance in order to ensure the compliance of the appropriate regulatory database and systems (RegPoint, CEDMS, ARTWORKS, etc, )
**Qualifications**
- Laurea magistrale in Chimica e Tecnologie Farmaceutiche, Farmacia, Chimica o Biologia;




- A minimum experience ( 6 months ) in Regulatory affairs
- Knowledge of the European and local legislation related to medicine, food supplement, cosmetic and medical device.
- Ability to conciliate the legislation requirements with the business strategy
- Knowledge of technical terminology in order to understand the regulatory documentation coming from manufacturing sites.
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-Lazio-Pomezia (Santa Palomba)
- **Organization**
Johnson & Johnson S.p.A. (7170)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206071852W