Regulatory Affairs Manager

Regulatory Affairs Manager

Centrient Pharmaceuticals

Rijswijk, Netherlands

 

The Position

The Regulatory Affairs department of Finished Dosage Forms business unit is currently seeking a Regulatory Manager to join their team. At Centrient, the drug product portfolio is extended with a range of sterile products and the vacancy is for a regulatory affairs manager with a strong CMC background who can guide and lead the regulatory submissions to license the products in Europe. This is an exciting challenging role with a high level of complexity for an experienced RA professional to combine dossier content knowledge and procedural regulatory experience. In this function you will report to the RA Director.

The main activities and responsibilities

  • Defining and execute the regulatory strategy for the new sterile drug product portfolio.
  • Initiate, lead, prepares robust regulatory applications to achieve departmental and organizational objectives.
  • Obtain MA’s via DCP/MRP in EU and via national procedures in EU for Centrient’s external customers, including responses to Health Authority questions during regulatory procedures.
  • Evaluating CMC documentation, data, validation reports required for generic sterile drug product dossiers.
  • Compilation of generic sterile drug product dossiers.
  • Cross functional alignment with all stakeholders (including external CMO).
  • Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs. Interacts with governmental regulatory agencies, other third-parties.
  • Have up to date knowledge of relevant new/draft legislation/regulation/guidance in the global regulatory affairs environment with specific emphasis on EU.

The Ideal Candidate

  • The ideal candidate has an academic degree in pharmacy, chemistry or in the biomedical field.
  • Has five to ten years of experience in European Regulatory Affairs of medicinal products, preferably in the generic pharmaceutical industry.
  • Has a strong CMC background preferably on sterile drug products.
  • Is experienced with management of EU regulatory procedures (DCP, MRP), is familiar with requirements, guidance in EU (ICH, EMA, CMDh, GMP). Any further RA experience on a global level will be regarded as an asset.
  • Has experience with document management systems (EDMS, eCTD).
  • Has strong project management skills and is commercially oriented to drive/prioritise projects.
  • Is able to operate effectively across multi-functional teams and enjoy working in a global team.
  • Is a person full of initiative, flexibility, and you are capable of analysing problems on a high level.
  • Is a natural builder of relationships and express your ideas clearly, with ease and flair.
  • Is able to identify opportunities and gaps and put operational and strategic plans in place to realize opportunities or fill gaps.
  • Is fluent in English, both on paper and face-to-face.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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