Johnson & Johnson Loopbaan

Senior Regulatory Affairs Associate, Regulatory Scientist

Beerse, België
Regulatory Affairs


Vacatureomschrijving

Requisition ID: 1805679592W

 Job Description

1. 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

• Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area

2. 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

 

3. 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

4. Clinical Trial Applications (CTA)

• 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

5. 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


Kwalificaties

 Job Requirements

Education and experience

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

• Experience in regulatory affairs

• Teamwork experience

 

Skills

• Project management skills

• Oral & written communication skills

• Organization & multi-tasking skills

 

Knowledge

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


Primaire locatie
België-Antwerpen-Beerse
Organisatie
Janssen Pharmaceutica N.V. (7555)
Functie
Regulatory Affairs
Requisition ID
1805679592W