Regulatory Affairs Specialist

Encontrado en: Talent ES C2 - hace 1 semana

Sant Joan Despí, España Neuraxpharm A tiempo completo

Neuraxpharm is the leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions.

The company has more than 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, and globally via partners in more than 60 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.

Neuraxpharm is searching a vacancy based in Barcelona, Sant Joan Despi:

Corporate Regulatory Affairs Specialist

Regulatory Affairs Specialist will ensure timely submission of complete/abridged applications for medicinal products in compliance with European regulations and guidelines.

BEING HIS/HER MAJOR ACCOUNTABILITIES:

Submission of MAA dossiers for NCEs, orphan products and generics for EU and non-EU countries Preparation of Module 1 of the MAA dossiers (in cl. Labelling, RUT, ERA) for the EU and the UK Compilation of MAA (Modules 1-5) in e-CTD incl. publishing Preparation and writing of selected sections of Module 2.3 and Module 3 Compilation of Modules 2-5 Monitoring of internally set deadlines for pending submission projects and monitoring of procedural deadlines. Active participation in DD processes/dossier audits Participation in working group meetings for various development projects for follow-up/preparation of documents for initial submission and ongoing process. Timely processing and submission of deficiency letters. Assist in the preparation and management of consultations and interactions with health authorities/external consultants (e.g. Scientific advice and clarification meetings). Regular communication with regulatory authorities, including building a sustainable network. Regular updating of internal databases

WE REQUIRE:

Solid knowledge of registration procedures/pharmaceutical regulation in e.g. Europe / Switzerland and UK. Minimum experience of 3-5 years in Regulatory Affairs in the Pharmaceutical Industry Experience in working with international contacts. Management of multiple projects and priorities and meeting critical deadlines. Experience in reviewing scientific information. Previous experience interacting with Health Authorities and Regulatory Agencies Key Capabilities: result-oriented, proactive, ability to deal with multiple priorities, strong interpersonal skills,

and attentive to details.

MS Office (Excel, Power Point, Word), Data management (RIM), e-CTD software English

WE OFFER:

Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy. Economic conditions will be according to the experience and skills provided. A motivated and committed environment based on a diverse and inclusive culture. A specialized team focused on our core activity: Improving our patients’ lives.

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