Sr. Manager RA - Animal Health
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 Netherlands.
The company develops and produces vaccines and pharmaceutical products for animals.
ROLE DESCRIPTION
As a Sr. 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.
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 procedures
- 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
- PhD. degree in any life sciences
- Knowledge of research, production and/or control of veterinary products is an advantage
- A minimum of 5 years experience with drug licensing
- Excellent communication and writing skills in English
- Experience with team management (specialised teams)
- Able to handle stress and strickt deadlines
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Linn Andenes.
