id:
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reference: 00660d44-050b-4a5d-aece-a35e67dd4ac1

documentId: WERKNL22169500

connectionPointId: 42

Functietitel: Senior Regulatory Affairs Manager

Functieomschrijving:
Senior Regulatory Affairs Manager (Netherlands)
Here at Lonza we have an exciting opening for an experienced Senior Regulatory Affairs Manager to join our ground breaking team in Maastricht/Geleen on a permanent full time basis. Maastricht/Geleen is Lonza’s center of excellence in Europe, in Cell and Gene therpay field (Advaced Therapy Medicinal Products (ATMPs)), accomodating manufactruing of drug products for both autologous and allogeneic therapy approaches from phase 1 up to commercial phase.

The Senior RA Manager will be expected to establish and lead a Regulatory Affairs department within Lonza Netherlands, providing regulatory support to the Maastricht and Geleen sites and to customers. You will also be responsible for supporting regional regulatory affairs project activities within the Regulatory Affairs function.

This position requires Fluen English language skills, both written and spoken. (Dutch would also be an advantage).

Provides regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc question to resolve regulatory issues. This will include:

Interprets EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of Emerging Technologies products.
Provides technical expertise and consulting to technical and business strategies
Functions as the regulatory contact in all direct communication with regulatory agencies.
Supports site-specific regulatory documents and activities
Updates functional leads and maintain transparency of information across regulatory function
Provides regulatory support for deviation and change control activities, as appropriate
Interprets and evaluates regulatory data to prepare documents and submissions, as appropriate
Drafts and/or reviews customer IMPD/INDs and customer MAA/BLAs
Provides support for scientific advice meetings and development of regulatory strategy with customers

numberOfPosts: 1

euresFlag: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2619

abstractJV_contact_0: Online application form

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Werkgever Naam: Lonza

source: NL