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Senior Regulatory Affairs Specialist

Auris Health

Auris Health

Legal, Sales & Business Development
Dublin, Ireland
Posted on Wednesday, August 23, 2023
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Description

Janssen Sciences Ireland, a Johnson & Johnson Local Operating Company (LOC) in Ireland, is recruiting for a Senior Regulatory Affairs Specialist, to be based in Airton Road, Dublin. This position will be in a hybrid model according to our J&J Flexible Work policy.

Are you ready to make a difference and join our new local Regulatory Affairs team? Together with the Head of RA in Ireland, you will be responsible for the management of regulatory activities for our broad product portfolio and groundbreaking pipeline.

Janssen is one of the world’s leading research-based pharmaceutical companies under the umbrella of the Johnson & Johnson family of companies – the largest diversified healthcare group in the world, with over 100 years of scientific heritage.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Key Responsibilities:

  • Actively participates in the lifecycle management of Janssen products, ensuring maintenance of regulatory compliance.
  • Provision of key strategic support to local Irish commercial business by communicating local RA expertise and knowledge.
  • Management of processes to ensure compliance with regulatory requirements and an inspection ready culture including:
  • Cross portfolio technical and administrative activities
  • Key therapy area regulatory support, including Integrated Brand Team (IBT) attendance as appropriate.
  • Compiling, reviewing, and submitting regulatory documentation to HPRA with support from ERMC as required.
  • Partner with allocated IBT to provide RA expertise and support implementation of Risk Management Plans, including leading cross functional team to update/implement Educational Material(s).
  • Building and sustaining positive relationships with the local health authority and ensuring Janssen representation in a regulatory trade association in order to lead and influence the regulatory environment changes and evolution
  • Preparing and managing local procedures following the EMEA Regulatory Affairs strategic plan, assuring timely execution and implementation.
  • Collaborating with other local functions (e.g., Quality, Safety, Supply Chain, Market Access, Medical Affairs, and Commercial) and providing them with relevant regulatory information.
  • Participating in artwork preparation and review activities.
  • Participating in and contributing to European RA initiatives/ projects.
  • Creating and updating local RA procedural documents.
  • Actively supporting the RA department to meet the goals and objectives, locally and at European level.

Qualifications

Experience

  • Primary degree in Pharmacy/Medicine/Biology/Chemistry or a related scientific field
  • Background working in the pharmaceutical/biotechnology industry with Regulatory Affairs experience (6+ years of regulatory experience preferred).
  • Direct experience and strong knowledge of Irish and European regulatory requirements and guidelines.
  • Proven experience working with HPRA.
  • Strong attention to detail skills, results orientation and collaborative approach.
  • Excellent interpersonal, communication, conflict management, negotiation and teamwork skills.
  • Proven ability to manage multiple tasks, projects, priorities, and complex systems simultaneously.
  • Fluent in English. Excellent written and verbal skills.
  • Knowledge of relevant IT systems and applications (e.g., MS Office).

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 are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Johnson & Johnson Family of Companies are equal opportunity employers and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other employment benefits and privileges. Please get in touch with us to request an accommodation.