Job Description

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders (CNS). We have a direct presence in 19 countries and plan further geographic expansion as part of our strategy to strengthen our position as a European leader in CNS treatments.

With its focus on CNS, Neuraxpharm develops and commercializes established brands, value added medicines, generics, Consumer Healthcare products, medical cannabis and beyond-the-pill-solutions and is continuously striving to offer a wide range of effective, high quality and affordable CNS treatment options in Europe.

Present with our products in more than 50 countries, Neuraxpharm also manufactures pharmaceutical forms and active pharmaceutical ingredients in our own manufacturing sites in Spain. With more than 900 professionals, Neuraxpharm has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is searching for a vacancy: Regulatory Affairs Specialist

Job Purpose

Management of EU countries like Greece, Cyprus and the non-EU countries like Switzerland, Canada, Australia New Zealand, Kazakhstan, Russia, Ukraine

Major Accountabilities

• Responsible for the preparation, managing, and submitting of variation packages for Labelling and Quality related variations to be submitted in the EU.

• Provide regulatory expertise for variation submission strategies to assure market presence.

• Coordinating and preparation labelling updates with the concerned EU authorities (via work-sharing procedures) incl. tracking the timely submission by local partners / local affiliates.

• Co-ordinating, review and approval for release of the artworks for printing

• Review and evaluation of dossiers to trigger regulatory activities, including completeness check / gap analysis.

• Implementation of dossiers in e-CTD, including baseline preparation

• Accompanying CMO transfers incl. update of the corresponding pharmaceutical dossiers

• Across department cooperation with the Pharmacovigilance (PV), Quality / Supply Chain (SC), International Trade Business (ITB)

• Direct communication, liaison, and negotiation to HA and/or with customer on-site/consultant

Minimum Experience

• Minimum experience of 4 to 6 years in a Registration department of the Pharmaceutical sector

• Adequate and solid knowledge of registration procedures/pharmaceutical legislation in a.m. countries

• Profound knowledge in the management of standard RA software like e-CTD / RI

• Degree in Pharmacy/Chemistry/Biology with complementary Postgraduate or Master’s in the Pharmaceutical Industry or/and Regulatory Affairs

• Proficient in English and one of the languages of the a.m. target countries

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