RA Project Manager
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Gelderland Netherlands.
The company produces a wide range of generic and innovative products.
ROLE DESCRIPTION
As a Regulatory Affairs Project Manager you will take part in the development of regulatory strategies for new and existing company products. You will further develop and manage Regulatory Submission project plans for several projects and ensure all regulatory requirements are met. You will report to the Sr. Manager of Regulatory Affairs.
RESPONSIBILITIES
- Development and implementation of Regulatory Strategies for assigned projects
- Prepare submissions for assigned new and existing products that are required to ensure timely approval for market release
- Responsible for the licensing for new products
- Interact with reviewers regarding product clearance as assigned, in consultation with the Sr. Regulatory Affairs Manager as appropriate.
- Develop clinically relevant content to support regulatory submissions and responses to regulatory inquiries by monitoring other activities related to assigned products and projects.
- Keep up-to-date on EMEA/FDA guidance and rule-making to anticipate regulatory changes that may impact future products and submissions
- Evaluate and document impact of proposed product changes on regulatory filings.
- Review labeling and promotional materials for assigned products for regulatory compliance
REQUIREMENTS
- Bachelor´s degree in a science related discipline (or equivalent)
- A minimum of 5 years of experience working with Regulatory Affairs
- Good understanding of both EMEA and FDA regulations and requirements
- Excellent communication and writing skills in English (and Dutch) with the ability to communicate and work at all levels of the organisation
- Ability to follow guidelines and effectively communicate scientific data in a structured manner
- Experience with working in teams
- Be capable of developing and maintaining professional relationships with internal and external subject matter experts
- Attention to detail
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .
