Student: CMC Regulatory Dossier Writer => 2021-2022 (Johnson & Johnson - internship / stage)

6-10-2020 beerse

Company Profile:
Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace innovation - bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration which has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives.

Department Profile:
The Dossier Development and Operations group is responsible for writing the Chemistry, Manufacturing and Control (CMC) sections of regulatory submissions and managing responses to related Health Authority (HA) questions for innovative synthetic and biological products across the Janssen portfolio.


The internship opportunity:
In the department of Dossier Development and Operations we currently have an internship position for a CMC Regulatory Dossier Writer (m/f). In this internship you will have the opportunity to participate with one or more project development teams on breakthrough medicines for unmet patient needs.

Job description:
The CMC Regulatory Dossier Writer is a key member of CMC pharmaceutical development teams responsible for writing CMC sections of regulatory submissions and managing responses to related Health Authority (HA) questions. The Dossier Writer uses their scientific knowledge and communication skills, in conjunction with strong project management skills, to drive the timely completion of high-quality submissions across the portfolio in Janssen R&D. He/she works closely with functional representatives (i.e., Analytical, Drug Product Development, API synthesis/manufacturing, Portfolio Management, Quality, Clinical Supplies, CMC Regulatory) to gather data and presents the appropriate information in a clear and concise manner that supports HA approval and advances the development and commercialization of medical products.

jouw aanbod

Your contribution:

Responsibilities and duties:
Working together with experienced colleagues, you will:
- author sections of the CMC dossier (i.e., Investigators Brochure, Clinical Trial Application, Health Authority Responses ...) and evaluate/ensure that final versions comply with regulatory requirements and fulfill regulatory agency expectations. You will ensure that all CMC dossier submissions for which you are assigned are completed in a timely manner.
- interact with, and support, the technical functions in the development of responses to health authority inquiries in support of clinical trials and potentially marketing applications.
- drive continuous improvement through efforts related to dossier template enhancement, process improvement, and advancing the understanding of regulatory requirements and expectations within the organization.
- be provided the opportunity to build broad experience of CMC aspects of pharmaceutical development by becoming part of the development team of one or more compounds and interacting with functional experts.
- follow a range of internal trainings related to various aspects of pharmaceutical product development.

- University study with a scientific focus.
- Good knowledge of English, both spoken and in writing
- Interpersonal skills to support team relationships.
- Ability to effectively collaborate.
- A keen eye for detail.
- Willingness to learn more about drug product development.

wat bieden wij?

Practical details:
- Location: Beerse, Belgium
- Allowance: We provide an allowance of € 20 per worked day, to cover for your daily expenses.
- Duration: 6-9 months
- Timeframe: NEXT ACADEMIC YEAR (2021- 2022) September-June

Requirement & How to apply for this position:
The candidate must be a registered student for the entire course of the internship.
Unfortunately, graduates that are currently not enrolled in a study program are not eligible for this internship.

If you are interested in applying for this challenging internship, please send an e-mail to, including your resume and a short motivation.

bediende boekhouding (m/v)
tijdelijke opdracht
Chemische en farmaceutische industrie
contact informatie
014-60 71 13
014-60 71 13