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Regulatory Affairs Executive - Global Pharma

Eingestellt von Real Staffing Group aus Frankfurt am Main

Projektbeschreibung

Global Pharma/Generics - Officer / Executive (Generics) £28- 33k

This global pharma/generics company is growing and expanding their team and is looking for a regulatory associate / office / executive

- Easy commute from - South East/ Hertfordshire/Cambridge/London/ Uxbridge/Watford, 30 minutes train from Kings Cross
-Benefits- Full healthcare-dentistry and medical, Pension, 25 days holiday per year, free Gym membership for the first month

This role requires:

At least 18months experience in Regulatory Affairs

* Working knowledge of submissions, Variations
* To track all applicable regulatory changes and commitments to approval; ensuring implementation and all relevant personnel are informed or communicated.
* To ensure change controls are managed correctly for the Regulatory Group and in compliance to approved procedures. (e.g. Spreadsheets, Databases and Trackers).

* To assist the Head of Regulatory Affairs to implement the Regulatory Affairs strategy for the EU.
* Manage the submission process (generally DCP, MRP, CP or national submissions) including responses to requests for further information from Competent Authorities, managing the national phase for MA issue following closure of the European Regulatory
* To undertake regulatory affairs work as required. To generate high quality regulatory submissions to target markets throughoutEuropein order to deliver a successful and timely portfolio of MA approvals in accordance with the company's requirements.
* Following MA approvals, maintenance of the MA approval activities including preparation and submission of variations and preparation for product launch. Successfully interact with the project and functional teams inIndiato ensure that data generated are appropriate and will be presented and compiled in accordance with EU requirements.
* Oversight of Regulatory Tracking Database. Liaise with contract services provider to ensure that the Regulatory Tracking Database is able to provide relevant and timely information on pending and approved products.
* Complete dossier submissions for projects in a timely manner.

* Working as part of the global team and liaising with global heads on a regular basis

This is a role where you will be working in a small team of a large growing Global Generics company with the opportunity to work in and learn new various tasks and procedures. This department are known for their training and development of staff.

This company emphasises on career progression and training and development. 12 months working for this company will be the equivalent of working for 18 months at a big pharma, due to the vast amount of exposure you will gain here.

They say good people know good people so if you know anybody who might be looking at the moment please do put them in touch with me. Please forward to friends or colleagues in the industry. Should I place anybody you recommend you will receive £200 of vouchers for John Lewis. Please forward this email, sometimes people are not actively looking until they see a good opportunity.

This is a great opportunity not to be missed, please send me your C.V or call me to discuss the role further

Natalie Hopkins on 02077587311 or n.hopkins(a)realstaffing.comTo find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland