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Regulatory Submission Associate
vor 2 Wochen
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Role Details:
Responsible for providing support to regulatory managers and others for the timely submission of information to Regulatory Authorities in support of investigational and marketed products. Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Fortrea groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and requirements. It is the responsibility of the Regulatory Associate to prepare documents to the required standard and to maintain awareness of current regulatory standards related to submissions for drug and biologic products
This role is 100% home based, anywhere in Germany.
Essential Job Duties:
- Assist with the preparation of study documentation such as the core EudraCT Form (Annex I, II & III) and cover letter.
- Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs and NDAs/MAAs/CTDs).
- Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.
- Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
- Maintain an awareness of regulatory legislation, guidance and practice pertaining to drugs and biologics.
- Monitor compliance with regulatory requirements in relation to assigned projects.
- Work on special regulatory projects as assigned.
Education, Skills and Other Requirements:
- Up to 1 year experience in the Pharmaceutical industry, preferably in Regulatory Affairs or Drug Development
- Some regulatory submission knowledge is required.
- Strong communication skills and motivation to support less experienced team-members
- Ability to work in a global and multi-cultural team setting
- Bachelor’s Degree in Life Sciences or equivalent
- Fluency in German and in English
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
Fortrea is proud to be an Equal Opportunity Employer:
- As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement._
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our
Privacy Statement
.
