Regulatory Affairs Manager - Barcelona, España - Centrient Pharmaceuticals Netherlands

Centrient Pharmaceuticals Netherlands
Centrient Pharmaceuticals Netherlands
Empresa verificada
Barcelona, España

hace 2 semanas

Isabel García

Publicado por:

Isabel García

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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 Regulatory Affairs department has a temporary vacancy in its Barcelona team for the following position:
The Position

Reporting to the Head of Regulatory Affairs EMENA, the incumbent will provide expertise in translating the business strategy of the specific region and the RA strategy of the different Franchises into a regional regulatory strategy and ensure submissions to the regulatory health authorities

Main Accountabilities

  • Lead and coordinate regulatory activities on assigned projects and/or products.
  • Ensure that time schedules are strictly adhered to as per the RA strategy.
  • Ensure that existing registrations of the specific area are maintained (changes, renewals etc.) for the APIs and intermediates manufactured by the company. Support FDF where required.
  • Ensure and maintain regulatory compliance for assigned products.
  • Prepare and review regulatory documents and dossiers.
  • Ensure the timely provision of highquality responses to all CMC related health authority questions. Supported by regional RA managers within department.
  • Prepare annual registration plans for assigned projects and products including all activities for new registrations and maintenance of existing registrations.
  • Ensure adequate use of RA documentation systems for document storage and archiving.
  • Compilation of CTD / eCTD dossiers within RIM database (Veeva) according to target countries technical standard.
  • Coordinate financial processes such as invoicing, payments, expense reports.

Requirements:


  • University degree in Pharmacy, Chemistry, Product Safety or similar degree or certificate
  • Minimum of 2 years' experience in a Regulatory Affairs / Quality role.
  • Knowledge of cGMP, ICH, CLP guidelines, regulations and laws.
  • Fluent proficiency in English language (written and spoken).
  • Nice to have: Veeva (RIM platform) experience.
  • Great communication skills in multicultural business environment.
  • Well organized, analytical and plan oriented.
  • Ability to create collaboration and partnership.
  • Maintain high focus on compliance.

Benefits:

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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