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Compliance and Regulatory Affairs Consultant

3 mesi fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

Position Overview:

As a Compliance and Regulatory Affairs Consultant, you will play a pivotal role in ensuring that our manufacturing site adheres to all necessary regulations and standards for sterile medicinal products. Your expertise will guide our clients through the complex landscape of regulatory requirements.

Key Responsibilities:

  • Collaborate closely with clients to facilitate the registration process for our manufacturing site.
  • Assist in formulating effective regulatory strategies tailored to the specific needs of our clients.
  • Draft and review the Common Technical Document (CTD) Module for new marketing authorizations, variations, renewals, and clinical trial applications.
  • Support clients in addressing inquiries and deficiency letters from regulatory authorities.
  • Coordinate with the Legal department and external partners for necessary notarization, legalization, and translation services for global registrations.
  • Ensure that all manufacturing processes and testing comply with the requirements of marketing authorizations and clinical trial applications.
  • Lead change control initiatives to ensure that all registration documents are accurately reflected in site documentation.
  • Conduct thorough gap analyses in preparation for regulatory authority inspections and identify corrective actions as needed.
  • Provide comprehensive regulatory support to ensure adherence to relevant laws, guidelines, and internal policies.
  • Participate actively in inspections conducted by regulatory authorities.
  • Assist the Regulatory Affairs Supervisor and Manager in preparing reports for the EU Regulatory Affairs function and maintain the regulatory affairs database.

Qualifications:

  • A degree in Chemistry, Pharmaceutical Technology, Pharmacy, Biology, or Biotechnology.
  • A minimum of three years of experience in a Regulatory Affairs department within an FDA-approved pharmaceutical organization, with a focus on sterile product manufacturing.
  • Proven expertise in drafting and reviewing CTD Module Drug Product documentation for sterile medicinal products.
  • Strong understanding of EU/US and global submission processes and documentation management.
  • Familiarity with applicable directives, regulations, Italian laws, cGMP, GMP Annex 1, and ICH/EMA/FDA guidelines.
  • Excellent written and verbal communication skills in English.
  • Strong analytical, communication, and interpersonal skills.

Thermo Fisher Scientific is committed to fostering a diverse and inclusive workplace. We encourage individuals from all backgrounds to consider joining our team.