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Prothya Biosolutions makes life-saving plasma medicines and is proud of it! Every day, Prothya colleagues are delighted to go the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible, fast-growing company with an interesting history? Then the position of Regulatory Affairs Officer International at our Regulatory Affairs International department might be something for you! At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn! Are you moving along? Then apply now!
Our new Regulatory Affairs Officer International will join an organization which is developing to a scale up phase, as our company is focusing on new business in new countries. This means that you, as our new Regulatory Affairs Officer International, will support registration activities internationally. Not everything is set in stone so there is a lot of room for your own input and improvements. Within the Regulatory Affairs department there is a dynamic team spirit with different backgrounds
Your job
- Coordinate, prepare, and follow-up with international registration submissions (final product and intermediates) via partners as Marketing Authorisation Holders, in a timely manner.
- Act as liaison with partners and internal organization to acquire required documentation for submission, as it relates to product changes and/or new product launches.
- Prepare/support international submissions with appropriate input/help from various functions (Regulatory Affairs, Commercial, Quality, Manufacturing, etc.) in a timely manner.
- Represent RA in product life cycle development teams by providing advice on the impact on international registrations.
- Resolve questions/handle queries from international registration authorities in the context of international registrations by coordinating and collecting specific registration information with RA, Commercial, Manufacturing, QA, Medical and other applicable departments as necessary.
- Coordinate and respond to requests for product information, surveys/questionnaires requested by partners.
- Assist with communication (e.g. prepare statements/justifications) or communicate directly with international regulatory authorities when needed.
- Ensure International Regulatory documents/records are complete, accurate and archived, and maintain overview of submission status of Prothya medicinal products registered internationally.
- Inform the internal organization of forthcoming changes in legislation and regulations and the possible impact on international registration dossiers.
- Advise and provide regulatory support to other internal departments in relation to international registrations.
- Provide regulatory support and advice to business partners that hold registrations for Prothya medicinal products.
- Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis related to RA international work.
Prothya Biosolutions is Marketing Authorization Holder (MAH) and producer of medicines derived from human plasma. The current product portfolio contains anticoagulants, immunoglobulins and albumin. Prothya Biosolutions also distributes medicines internationally via partners who are MAH of Prothya products.
The RA department is in charge of gaining and maintaining product registrations at the health authorities and consists of 13 team members. There are six RA Officers in the EU/US/UK RA team, two RA Officers in the International team, two RA Team Leads, PMF Lead, RA Coordinator and the Director of RA leading the department. This vacancy is to join the RA International team (team of four).
Your profile
- A Bachelor degree in Pharmacy, Biology or Biochemistry
- At least 2-3 years of experience with international registrations (Asia, South America) of biological products
- Knowledge of the process of export dossiers and EU registration
- Experience with working in projects
- Fluency in English is a must and Dutch is preferably
As Regulatory Affairs Officer International
- You are assertive and detail oriented, with advanced communication skills and are able to coordinate within larger teams with harmony
- You are an achiever and positive, and able to support commercial requirements with a flexible approach
- You take initiative for instance to improve processes and you work well under pressure.
Our offer
The following employment conditions apply:
- Full-time employment
- 8.33% end of year bonus and 8.33% holiday allowance
- Flexible working hours in consultation
- Personal training budget of €2,000 per 3 years
- Contribution to travel expenses from the first kilometer
- Good accessibility by public transport and private parking
- Pension plan at PFZW.
More info
If you would like to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your resume and motivation via the apply button on this page. We aim to respond to you within a week.
Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.