Challenging position for the real go-getter within Regulatory Affairs for a large international pharmaceutical company.
Job Description
We are looking for an experienced person to fill this challenging all-round position. Focus areas will be: Regulatory Submissions, Labeling and Artwork, coordination of Modules 2, 3, 4 and 5, and much more. The duration of this position initially is 6 months.
Responsibilities
- Coordination for new and authorized pharmaceutical product through timely preparation for submission of variations, renewal applications, PSURs and any other necessary application/notification.
- Responsible for correct/complete intake of the documents and procedure that trigger initiation of introductions / changes.
- Collecting all necessary information for preparation of new product labeling, such as technical specifications, design specifications, registration requirements and texts.
- Reviewing Modules 2, 4 and 5 as well as coordination of Module 3 improvements (CMC or other programs).
- Contact person for internal and external stakeholders such as, Packaging sites, External artwork center, Regulatory entities, Supply Chain-, Regulatory- and QA-departments.
Requirements
- Bachelor degree in a life science related field.
- Excellent communication skills (fluent in English) as well as organization and planning.
- Senior level working experience in a fast paced environment with high volumes of work within RA or related field.
- You are focused, determined, problem solving, and business keen.
- You have a valid work permit for EU.
Benefits
- Contract: 6 months via Oxford.
- Salary: €4000 - €5500 gross monthly based on 40 hours.
- Working hours: 32-40 hours.
- Region: Oss.
- Vacancy number: 18594.
