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 ...
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Biologics B.V.</STRONG>, we are searching for a Regulatory Affairs Scientist.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
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.
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.
Liaise 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 Authorisation Applications (MAA) in EMEA region:
- 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.
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.
Who we're looking for
The ideal candidate has an MSc in Life Sciences (pharmacy, biology, veterinary etc.) with at least 3 years of relevant regulatory experience. You have knowledge of the regulatory environment, guidelines and practice of EMEA regions, international team work experience is a plus. Do you have project management skills and excellent communication skills? Then we are looking for you!
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 6 months, extension anticipated but no guarantees yet. 32 hours ideal, 24 hours discussable for seniors. Remote work possible with minimal commitment of 1-2 days in Leiden (depending on seniority).
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555
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