Sr. Manager, Regulatory Affairs Lead Italy - 2406200884W

Description

Johnson & Johnson is currently seeking a Sr. Manager, Regulatory Affairs Lead Italy to join our Regulatory Affairs Department located in Pomezia, Rome.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

DE&I Statement

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Senior Manager, Regulatory Affairs (RA) Italy serves as the RA Leader for Italy for the MedTech business, covering Orthopedics, Surgery and Cardiovascular & Specialties Solutions.

This position leads the team of RA professionals responsible for ensuring that products (medical devices and medicines, when applicable) distributed by Johnson & Johnson Medical S.p.A Franchises conform to Regulatory Requirements and support Marketing Organisation to fulfil regulatory requirements. The position ensures relationship with Competent Authority is maintained to address regulatory and pharmacovigilance related inquiries.

This position represents RA in the Italian Commercial Leadership Team, to understand strategic priorities and align RA strategy with functional and business strategies. Serves as the spokesperson for the functional area. Provides regular functional updates, flagging regulatory risks, co-operating with commercial team leaders, and supporting functions to ensure uninterrupted product supply.

Key Responsibilities:

• Leads the RA organization to ensure activities as described below are duly managed.

• Ensures collaborator management, professional growth, and motivation, in line with company policies and indications.

• Suggests and implements efficient and effective process solution and improvements to meet organization goals.

• Takes part in the strategic commercial team meetings to understand business goals and ensure coherence with regulatory requirements.

• Acts as the primary local contact for the Italian MOH for Vigilance and Regulatory issues.

• Responsible for the management of Ministerial Repository for CE marked devices and for the Management of Local Product Portfolio.

• Cooperates with Legal Manufacturers for the preparation and submissions of dossiers for clinical trials to Italian Ministry of Health, in compliance with application of Medical Directives 93/42 and MDR, as well as local transpositions. Participates in meetings with legal manufacturers / authorized representatives for setting the strategy of submissions to Italian MOH, when needed.

• Conduct the activity of Pharmacovigilance (PV) for medicines distributed by Johnson & Johnson Medical S.p.A. as local PV Contact according to the role required by art. 17 of Ministerial Decree of 30th April 2015, in coordination with the Pharmacovigilance Qualified person of the Marketing Authorization Holder. The function assures 24hours availability.

• Ensure promotional materials generated by Franchises or by local Marketing dept. are properly reviewed from a regulatory perspective and in compliance with medical device directives and MDR before being published in any format (including web sites) and not advertised to end users, where applicable, without prior authorization of the Competent Authority.

• Ensures, when requested by the manufacturer or Authorized Representative, that Instruction for Use and labels of marketed products are correctly translated in the local languages.

• Helps the Tender Office and Marketing Depts. generate declarations in relation to technical characteristics of the marketed products and to assure that regulatory documentation is updated and available for all the necessary use.

• Takes care of all administrative procedures with the Ministry for Health and other Authorities involved for obligations required by MDD 93/42, and EU Regulation 2017/ 745 and connected regulations.

• Assists Medicinal manufacturer and Local Marketing Organization in managing the regulatory procedures for the distribution of drugs in relation to the drug registration, price dossier preparation, medical information according to requirements set by Drug Directive 2001/83 and local transposition (Decree 219/06).

• Provides regulatory advice to project teams.

• Supports legal dept. in managing legal issues that include regulatory aspects.

• Cooperates with local BQ Lead in managing internal and external audits on Scientific information (Drug sale reps’ activities) on distributed drugs.

• Support local Safety and Environmental dept. in applying and interpreting the Environmental laws (WEEE, Battery, ROHS, REACH, CLP etc.)

• Regulatory support to fulfill Notification obligations to local Authorities, in compliance with local transposition of WEEE and Battery directives.

• May act as the LAA ( Local Actor Administrator) within Eudamed.

Qualifications

Education:

• University / Bachelor degree or equivalent - Technical-scientific decree or equivalent experience.

Experience and Skills:

Required:

• Extensive working knowledge of Regulatory Legislation in Europe and Italy on Medical Devices, Drugs and Environmental requirements pertaining to distributed products.

• Extensive knowledge of Medical Devices Quality Management Systems.

• Minimum experience of 10 years in regulatory affairs.

• People management experience

• Italian and English: (English level - possibly referred to ALTE lists, other entities, etc.)

o Advanced Level – ALTE C2 – CAE

• Ability to interact with Trade associations and Authorities for advocacy activities.

• Strong communication skills to leverage interaction with Health Authorities.

• Attitude to comprehend the Regulatory environment and understand the impact on the Company Business.

• Understanding of the linkages in Vigilance and Regulatory Compliance in delivery to customer and Health Authority.

• Strong collaboration skills and ability to build partnerships internally and externally.

• Ability to effectively present information to Management and public groups

Primary Location Europe/Middle East/Africa-Italy-Lazio-Rome

Organization Johnson & Johnson Medical S.p.A. (7257)

Job Function Regulatory Affairs

Req ID: 2406200884W