(Senior) Regulatory Affairs Officer

Functie beschrijving

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Wat je gaat doen
Are you an enthusiastic Regulatory Affairs (RA) professional looking to work in an RA department located on the same premises as the production facilities for biological medicines? Do you want to play a meaningful role in the eradication of polio worldwide? Then this position at the RA department of Bilthoven Biologicals (BBio) is your opportunity

Depending on your competencies and experience, you will work as a senior RA officer under the leadership of the manager RA in a team of 4-5 other (senior) RA officers in one or more core activities of the RA department:

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• Preparation and submission of regulatory dossiers to obtain new product registrations in countries worldwide
  
• Maintenance of regulatory dossiers of registered vaccines both nationally and abroad
  
• Initiation of variations in response to change control procedures, changed regulations, or at the request of authorities, and implementation and coordination of resulting actions
  
• Critical review of source documents from other departments such as Quality Control (QC), Manufacturing Science & Technology (MS&T) or Production, such as validation, comparability, and stability reports, to ensure these documents are suitable for submission to regulatory authorities
  
• Participation in projects that have an impact on the regulatory dossier, e.g. new presentationsor major changes in the manufacturing process
  
• Maintenance of contact with the external company that performs the pharmacovigilance tasks on behalf ofBBio
  
• Maintenance and setting-up of various regulatory IT systems such as XEVMPD, IDMP, PMS, and the creation of eCTD sequences
  
• Maintenance of internal and external relationships with consultants, agents, and national and overarching regulatory authorities such as the EMA, MEB, and WHO
  
• Identification and interpretation of changed and/or new laws and regulations for marketing authorizationsworldwide
  
• Provision of(un)solicited advice and responses toquestions about the regulatory dossier from other departments
  
• Coordination of the creation or modification of pharmaceutical artwork, contact with artwork printers
  
• Determination and set-up ofthe regulatory strategy for current and new regulatory procedures, in collaboration with the manager RA
  
• RepresentRA in projects with other departments (including MS&T and M&S) at an early stage, assess impact on product registration proceduresin a timely manner
  
• Collaborate closely with other departments/colleagues such as MS&T, Marketing and Sales (M&S), Quality Control (QC), Quality Assurance (QA) and Qualified Persons (QPs)
  
• Performing final editing on all regulatory dossier documents
  
• Writing of RA department procedures
  

Functie eisen

Wat neem je mee
To be successful in this role, you should have:

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• University working and thinking level, i.e. an MSc. degree in a biomedical discipline or BSc. degree in a biomedical discipline supplemented with significant RA work experience
  
• Knowledge of international regulatory guidance and marketing authorization procedures for biological medicines, including regulatory dossier granularity and eCTD basic knowledge (ICH M2)
  
• Excellent command of the English language, both spoken and written
  
• Minimum of 3-5 years’ relevant RA work experience, gained within an international environment
  
• Affinity with electronic regulatory databases
  
• Strong awareness of regulatory compliance and GMP
  
• Knowledge of pharmacovigilance is highly desirable.
  

Wij bieden

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• A salary betweenScale 10 & 11 (€3.868to €7,484 gross per month based on a 36-hour work week), depending on your knowledge and experience.
  
• A contract for 32 to 40 hours per week.
  
• A sustainable employability budget of €350 per year.
  
• A dynamic, socially driven work environment.
  
• An excellent travel allowance scheme.
  
• A year-end bonus (13th month salary) and a solid pension plan.
  

The values and competencies associated with this position, are openness, cooperation, ownership, delivery, positivity and agility.

Overige opmerkingen

De afdeling
The RA department manages the regulatory dossiers of all BBio products and ensures that changes in the vaccine manufacturing process are assessed in terms of impact on the regulatory dossier. When a change in production has impact , the RA department determines the regulatory strategy in consultation with other departments and submits variation applications to the regulatory authorities. The un