Senior Regulatory Affairs Specialist

Job Description - Senior Regulatory Affairs Specialist (2506235204W)

Senior Regulatory Affairs Specialist - 2506235204W

Description

Johnson & Johnson Innovative Medicine 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.

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.

Are you ready to make a difference and join our new local Regulatory Affairs (RA) team?

As a member of the RA in Ireland, you will be responsible for the management of regulatory activities for our diverse and innovative product portfolio which spans multiple focus areas.

Main duties and responsibilities : Actively participates in the lifecycle management of 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 J & J 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.QualificationsPrimary 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).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.

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"!

Primary LocationEurope / Middle East / Africa-Ireland-Dublin-Dublin

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our page for information on how to request an accommodation.

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