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Senior Regulatory Affairs Manager

Locatie

Netherlands or Sweden

Bedrijfsprofiel

Sever Pharma Solutions provides long-standing experience in the technologically demanding area of polymer-based delivery systems. In this area, experience makes the difference because explicit dosage form-related regulatory guidance is lacking; selection and sourcing of polymeric excipients is an expertise in itself; and interactions between polymer and drug substance may be complex.

Sever Pharma Solutions has unique (co)-extrusion capabilities, the readiness to manufacture investigational medicinal products for clinical trials, and the ability to handle drugs in the highest occupational exposure bands.

It is their philosophy to be a transparent and flexible development partner, willing to step in at any point of the development process.

As in earlier stages of development, Sever Pharma Solutions work according to relevant regulatory guidelines and follow principles such as Quality by Design and Design Control for pharmaceutical products and devices, respectively. They are also highly experienced in the development of combination products and can help customer’s to navigate this regulatory pathway, providing relevant supporting documentation for their submission.

A key part of the later development of any pharmaceutical product is establishing a design space, whereby the influence of critical material attributes and process parameters on the final product is thoroughly understood. Sever Pharma Solutions can demonstrate that the product is manufactured to the highest quality. This knowledge is generated through applying a Design of Experiments (DOE) approach to development trials, to give maximum information with minimal effort. By continuing to partner with them in commercial manufacture, customers can be assured that this knowledge will follow the product through to production, resulting in the consistent manufacture of a quality product using a robust process.

Approval of the customers’ product is their common goal. They know what it takes to get there and have this goal in mind from the earliest stages of development. This makes the transition from earlier development to late development as smooth as possible for products that they have been involved with from the start. They can also work towards a seamless tech transfer of a product from another site and ensure that further development and manufacture is conducted according to the customers’ needs. Their experience includes the supply of batches for late phase clinical trials, process validation, and the manufacture of registration batches. Following approval of the product, they can take the step to commercial manufacture together with the customer.

Sever Pharma Solutions put the customer in focus, and give excellent service as part of their culture. One of their strengths is their ability to be flexible and solve challenges that arise during a project’s life cycle. Good communication with customers is one of the most important things to reach success.

Functieomschrijving/taken

Purpose of the role:

You will report directly to the EURAM Regional Customer Support Director.

  • You will work strategically and operationally across the EURAM Region with Customers, Dealers and Partners.
  • A key success factor for this role will be the ongoing training, education & knowledge development of local aftersales support teams, before, during & after all Smart Data Solutions (SDS) Hardware, ID & Traceability projects.
  • You will be a key point of contact for the region, on specific strategic projects & initiatives as part of the Professional Services provided by EURAM Regional Customer Support.
  • As part of the EURAM Regional Customer Support Leadership team, you will focus on how to deliver SDS, by effective site analysis, hardware specification & recommendations, ensure effective local implementation.
  • You will be responsible for strategically managing all the SDS Hardware, ID & Traceability for Customers, Dealers and Partners, across the EURAM Region, and supporting local operations.
  • You will liaise directly with global departments, regional General Managers & local business units/teams to prioritize local traceability projects.
  • Effective delivery of all SDS Projects is vital, and you will be responsible for the collaboration of regional & local teams and partners to ensure effective agile project management & delivery.
  • You will need to develop the vision, apply the drive & determination, and demonstrate ownership & accountability to ensure successful execution of all EURAM Regional traceability projects.

Profiel kandidaat

Required:

  • A Master’s degree in biological, pharmaceutical, chemical or engineering sciences is preferred.
  • A minimum of 8-10 years of experience in the regulatory field, including relevant and demonstrable experience with drug products, combination products and/or medical devices is required.
  • Direct and significant (8-10 years) experience in writing CMC documentation for INDs, ANDAs, NDAs and/or MAAs.
  • In depth knowledge of ICH, EMA and FDA regulations and guidance on drug products and/or drug-device combination products.
  • Direct experience in orchestrating and leading meetings with Health Authorities (EMA and/or FDA)
  • Advanced knowledge of the pharmaceutical drug development process.
  • Basic knowledge of how QbD principles can be applied in design space and further in the regulatory framework.
  • Direct experience in developing regulatory strategies in compliance with regulatory requirements.
  • In-depth knowledge of the registration procedures for drug and drug-device combination products in Europe and the US.

Contactpersonen

Information & application

Marije Hoogendoorn | Sr. Recruitment Specialist

+31 - 6 - 23 13 51 18 | hoogendoorn@themagroup.nl

Marjo Lucker | Recruitment Consultant

+31 - 6 - 13 56 19 88 | lucker@themagroup.nl

Publicatie datum

06.08.2021
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Duitsland

Merowingerplatz 1
40225 DUESSELDORF
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België

BioVille, Agoralaan
Building A bis
B-3590 DIEPENBEEK
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Pivot Park Kloosterstraat 9 
5349 AB OSS
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Odiliastraat 92
5401 ZZ UDEN
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