Global Regulatory Affairs Biotech Director

Contratto: Indeterminato
Sede: Milano - Italia

The Regulatory Director has the responsibility to define, coordinate and implement regulatory plans, with focus on development. Leads the preparation of new dossier and implementation of regulatory strategies at local level (affiliates). Represents regulatory at internal inter-functional meetings, with external partners and entities, with reference regulatory institutions.

The candidate will report to the Chief Regulatory Affairs and Drug Safety Officer and will be ideally based in the company HQ in Milan.

Are you a regulatory affairs expert looking for a next step to develop your career within an innovative R&D organization?

We are looking for a talented Director with extensive global regulatory experience and excellent interpersonal skills. The Director will cover different areas of regulatory affairs:

Principali aree di responsabilità

  • As Regulatory Business Partner you will lead the decision regarding the regulatory aspects of the assigned products/countries from the preparation of Marketing Authorization to post-approval activities working in close collaboration with other functions and/or external partners and consultants.
  • You will serve as global key strategic partner with marketing, medical affairs, market access and other functions for the activities related to launch of the products (i.e. for promo and no-promo materials).
  • As Regulatory Development expert you will contribute in define strategies related to CTA/IND submission and you will contribute to the preparation of the applications as well collaborating with the cross-functional team including Clinical Development, Biostatistics, Non-clinical, CMC, Commercial etc.
  • You will also lead and manage the preparation and follow-up of meetings with the main Health Authority across the world, in alignment with Company’s strategies.
  • For all the assigned projects you will proactively counsel teams and interpret health authority feedback, regulatory guidelines and policies to drive medicine strategies for both commercialized and investigational products.

Requisiti

  • Degree in scientific disciplines (e.g. Pharmacy, Biotechnology);
  • Fluent in English language;
  • 8-10 years experience in regulatory affairs of HQ companies with R&D;
  • Advanced knowledge of regulatory requirements for global clincal development of drugs to support marketing authorization;
  • Relevant experience in leading Scientific Advice and meetings with FDA and EMA.
  • Experience in the areas of ophthalmology, cancer or diabetes is a plus.
  • Reference Pharmaceutical market, current trends and competitors (in terms of Company goals, competitive positioning and main initiatives)
  • Focus on global development
  • Process and tools of communication and information
  • Marketing Plan
  • Organization, processes and internal procedures
  • Scientific knowledge of the products
  • Project Management and Planning
  • Reference medical disciplines
  • Scientific communication
  • Pharmacovigilance
  • Institutions and regulations: National, international and Regional regulations within pharmaceutical industry
  • Codes of professional conduct in the Pharma industry
  • Avaialble to travel.

SOFT SKILLS

  • Leadership and Authority
  • Strong Project Management attitude
  • Decision-making
  • Delegation and Development
  • Integration and Internal Networking
  • Entrepreneurship, Individual exposure
  • Inclination to result, Pragmatism
  • Systematic analysis and review
  • Innovation
  • Processmonitoring
  • Communication
  • Focus on learning and professional update

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Dompé farmaceutici S.p.A. Socio Unico / Capitale sociale € 50.000.000,00
REA MI 289519 - Registro Imprese di Milano / Codice Fiscale e Partita IVA (VAT) IT00791570153

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