(Senior) Regulatory Affairs Officer

Carriereinutrecht; Bilthoven; On-site; EUR 43,000 - 84,000; Full time

Benefits offered by this job

Salary scale 10–11 (€3.868–€7.484 brut

Contract 32–40 uur per week

Travel allowance

13th month bonus

Pension plan

Sustainable employability budget

Job summary

Bilthoven Biologicals zoekt een Regulatory Affairs professional om op de locatie mee te werken aan dossiers en regelgeving voor biologische geneesmiddelen. Je werkt in een team van RA-collega's en rapporteert aan de RA-manager.

Je bent verantwoordelijk voor dossiervoorbereiding, variaties en communicatie met EMA/WHO/uff. Ervaring met internationale regelgeving en eCTD is vereist en Engels is essentieel.

Qualifications

• MSc in biomedical discipline or BSc in biomedical with RA experience.
• Kennis van internationale regelgeving en marketingauthorisatieprocedures voor biologische medicijnen (ICH M2/eCTD).
• Uitstekende beheersing van het Engels (mondeling en schriftelijk).
• Minimaal 3–5 jaar RA-werkervaring in een internationale omgeving.
• Affiniteit met elektronische regulatory databases.
• Sterke kennis van GMP en regulatory compliance.
• Kennis van pharmacovigilance is zeer gewenst.

Responsibilities

• Voorbereiding en indiening van regulatory dossiers wereldwijd.
• Onderhoud van regulatory dossiers in binnen- en buitenland.
• Initiëren van variaties en coördineren acties bij verandering of regelgeving.
• Beoordelen van documenten uit QC/MS&T/Produktion voor submission aan regelgeving.
• Deelname aan projecten met impact op het regulatory dossier.
• Contact onderhouden met externe pharmacovigilance-provider.
• Onderhoud en opzetten van regulatory IT-systemen (XEVMPD, IDMP, PMS).
• Samenwerking met MS&T, M&S, QC, QA en QPs.
• Uitvoeren van eindredactie op dossierdocumenten.
• Schrijven van RA-afdelingsprocedures.

Skills

Regulatory Affairs

International regulatory guidance

GMP awareness

Pharmacovigilance

English proficiency

Electronic regulatory databases

Education

MSc Biomedical

BSc Biomedical with RA experience

Tools

XEVMPD

IDMP

PMS

Job description

Functie beschrijving

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:

• 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:

• 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

• 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 uniqueness of the RA department of BBio is that it is located on the same premises as the GMP production and testing facilities;in other words,there are many direct F2F contacts between the RA colleagues and the colleagues in the production facilities; as an RA professional, you are literally very close to the action, which is quite unique in the Netherlands.

In addition to all activities directly related to vaccine production, the RA department is also responsible for managing artwork, packaging, and product information, ensuring compliance with pharmacovigilance legislation in collaboration with an external pharmacovigilance service provider, and maintaining contact with clients and regulatory authorities worldwide.

There are also very concrete plans to register and market existing BBio products in new EU countries. In addition to existing products, BBio also wishes to register two new products in the EU, making expansion of the RA team a high priority.

Over ons
Bilthoven Biologicals is an internationally operating biopharmaceutical company. Approximately 500 colleagues work together on the manufacture of vaccines, such as polio, tetanus, and diphtheria-tetanus-polio (DTP) vaccines and the immunotherapy product BCG. BBio supplies polio vaccines to UNICEF, and other partners, for the global World Health Organization (WHO) program to eradicate polio worldwide. Since 2012, BBio has been part of the Cyrus Poonawalla Group, owner of the Serum Institute of India, the largest vaccine producer by volume in the world. Additionally, BBio is investing in modernization and expansion of its production capacity.

Het bedrijf

Bilthoven Biologicals is een internationaal biofarmaceutisch productiebedrijf. Met circa 500 collega's werken we samen aan de productie van vaccins, zoals polio-, difterie-tetanus-polio (DTP) en BCG. BBio levert vaccins aan onder andere de World Health Organization (WHO) en UNICEF en helpt zo mee aan het wereldwijde programma om polio de wereld uit te helpen. BBio maakt deel uit van de Poonawalla Group, eigenaar van het Serum Institute of India, de grootste vaccinproducent ter wereld.