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EMEA Regulatory Affairs

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Location Leiden, South Holland Salary competitive
Sector Life Sciences Type contract

Job title: EMEA Regulatory Affairs - Scientist

GRA Department:

Global Regulatory Affairs; EMEA Therapeutic Area Immunology. Janssen R&D, member of the Johnson & Johnson's Family of Pharmaceutical Companies, Therapeutic Area Immunology, located in Leiden by Janssen Biologics BV.

The Consultant RA Scientist will work with the EMEA Regulatory Liaison hand in hand with the commercial arm of the EMEA (Europe Middle East and Africa) organization to ensure rapid market access of our products and optimal support of products already on the market. The team also provides regulatory support through the entire product life cycle, by providing regional regulatory strategy, advice, HA communications and support submissions, for EMEA products and EMEA Regulatory activities through development and product life-cycle.

Description

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

Liaison with Regulatory Agencies and Local Operating Companies

* Act as back-up for contact with Regulatory Agencies as needed
* Assist in the preparation of meetings with Regulatory Agencies
* Draft cover letters for Regulatory Agency communication
* 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



Support of Marketing Authorization Applications (MAA) in EMEA region:

* 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

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 time lines

Qualifications

* University degree in Life Sciences (pharmacy, biology, veterinary etc.), or equivalent by experience;
* Minimal 3 years of relevant Regulatory experience
* International team work experience is a plus

Skills

* Project management skills
* Oral & written communication skills
* Organization & multi-tasking skills
* Fluent in English

Knowledge

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

If you have interest in this position, or any question regarding the specifics of the job, please send me an email with your CV + Cover letter, or question at: j.vanbaalen(@)progressive-nl.com