Regulatory Affairs Analyst - Sant Feliu de Llobregat, España - Centrient Pharmaceuticals Netherlands

Centrient Pharmaceuticals Netherlands
Centrient Pharmaceuticals Netherlands
Empresa verificada
Sant Feliu de Llobregat, España

hace 2 semanas

Isabel García

Publicado por:

Isabel García

beBee Recruiter
Descripción
Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.
We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines.

With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers' needs.

We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.
Founded 150 years ago as the 'Nederlandsche Gist
- en Spiritusfabriek', our company was known as Gist Brocades. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.
The Innovation & Technology Development department has a vacancy in its team for the following position:
Regulatory Affairs Analyst (Innovation & Technology Development)

Supporting the I&TD organisation and contributing to achieve the objectives of the department which are:

obtaining global approval for CENTRIENT APIs, including the lifecycle management of the registrated DMFs according to business planning and supporting the innovation activities of the I&TD laboratory.

The main activities and responsibilities

  • Collection of information and administrative documents and assist in preparation of DMFs and variation packages as and when required.
  • Coordination of administrative tasks such as regulatory fee payments, update of health authority portals, translations, generation of CEP and ASMF LOAs, API related statements etc.
  • Generation of eCTD sequences via EXTEDO, and potential final registration of these to authorities via CESP portal, Webtrader, etc.
  • Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures.
  • Archiving documents and data in electronic archive systems, e.g. Veeva.
  • Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the (administrative) RA environment.
  • Internal alignment relation to regulatory updates, variations packages, and regulatory procedures.
  • Contribute to write SOP's and write and review work instructions related to department.
  • Report all regulatory data related to activities to ensure RA work plan and other databases are up to date.
  • Escalating to senior staff in case of complexities.
  • Execute purchasing administrative activities.
  • Administer documentation in Master control and documentation archive management in Sharepoint.
  • Organize sample shipping.
  • Management of lab equipment maintenance & calibration schedule.
  • Laboratory inventory.
  • Electronic lab notebook administration.

Requirements:


  • Academic degree in a relevant life science field such as Pharmacy, Chemistry, or related life science degree.
  • 12 years of experience in regulatory affairs and/or relevant health registration environments of medicinal products, preferably in the generic pharmaceutical industry.
  • Knowledge of Pharma Industry regulations.
  • Basic Regulatory Affairs and Quality mindset knowledge.
  • Experience in EDMS, Mastercontrol, IT tools...
  • Fluent in English language (written and spoken).
  • Accuracy, creativity, troubleshooting capability.
  • Pragmatic.
  • Commercial competence, service minded and time management skills.
  • Strong communication skills able to operate cross functionally.
Terms and reward

We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals.

The organization is very flat. You have a lot of freedom and responsibility in an open, direct, and informal atmosphere.

The Procedure
Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.
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