Join BioBusiness Summer School to jumpstart your career in Life Sciences by gaining knowledge of business aspects such as product development, IPR, finance and business models. The next edition of the summer school will be organised from 24-28 June 2019 in Amsterdam, the Netherlands.
Regulatory Affairs Scientist
For our client Janssen Biologics B.V. we are searching for a Regulatory Affairs Scientist.
As RA Scientist, you will work with the EMEA Regulatory Liaison hand in hand with the commercial arm of the EMEA (Europe Middle East and Africa) organisation 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.
Your responsibilities are:
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.
- 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.
- 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.
- Provide regulatory support throughout registration process and 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.
- 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.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
Publication end date
Jumpstart your career
The BioBusiness Summer School is a programme tailored to bridge the gap. By immersing yourself in the business aspects of Life Sciences during this programme, you will learn the basic knowledge of BioBusiness, gain insight in the world of Life Sciences companies, meet leading business leaders and increase your international network.