Regulatory Affairs Specialist

Regulatory Affairs Specialist - EMEA

Location:  Beerse - Belgium (remote)

Travel: May require 10% travel

Project Description:

Regulatory affairs professional who can support the regional regulatory strategy for products in the oncology pipeline, preferably with experience of clinical trial applications, scientific advice procedures, paediatric investigational plans or EU marketing authorisation applications and variations.

Job Description / Responsibilities:

Input in development, post-approval and Life cycle management

• Participate in global regulatory team meetings as appropriate

• Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned

• Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic area

Liaison with Regulatory Agencies and Local Operating Companies

• Act as back-up for contact with Regulatory Agencies as needed

• Draft cover letters for Regulatory Agency communication

• Assist in the preparation of meetings with Regulatory Agencies

• Liaise with LOCs, track and respond to queries in a timely manner

Input in document and process development

• Assist in development of processes related to regulatory submissions

• Draft and review some document content (depending on level of regulatory knowledge / expertise)

• Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed

• Track dates of submissions and Regulatory Agency responses

Clinical Trial Applications (CTA) - essential

• Review protocols and ensure alignment with regulatory requirements

• Advise team on required documents and submission strategies in preparation of CTAs

• Ensure CTA submission packages are complete and available according to agreed timelines

• Review and approve clinical trial supply plans

Marketing Authorization Applications (MAA)

• Provide regulatory support throughout registration process

• Provide regulatory support throughout life-cycle management

• Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)

• Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities

• Assist with submission and acceptance of MAA

• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans

how to succeed

Education / Experience 

• University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience

• Experience in regulatory affairs

• Teamwork experience

• Project management skills

• Oral & written communication skills

• Organization & multi-tasking skills

• Knowledge of the regulatory environment, guidelines and practice of EMEA regions

What’s in it for you?  

As the biggest health company in the world, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment where everybody feels welcome and respected. 

At Johnson & Johnson, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.  

https://www.janssen.com/belgium/

Benefits

This role offers a very competitive hourly rate. 

you are welcome here

Johnson & Johnson is 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.

about Johnson & Johnson

At Janssen Pharmaceuticals, we strive for one big goal every day: a future in which diseases like cancer, IBD, HIV and COVID-19 are a thing of the past. We research to prevent, treat and cure the most serious diseases. Our entire team works every day to develop and provide access to innovative therapies for people worldwide. We are tirelessly on the lookout for new solutions and opportunities for cooperation. We never give up, even in supposedly hopeless situations. That is the Janssen spirit.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

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 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”