Senior Regulatory Affairs Specialist

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.

Learn more at https://www.jnj.com/.

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.

Qualifications and Experience


* Primary degree in Pharmacy/Medicine/Biology/Chemistry or a related scientific field


* Background working in the pharmace...