Manager, Regulatory Affairs - Ferentino, Italia - Thermo Fisher Scientific

Thermo Fisher Scientific
Thermo Fisher Scientific
Azienda verificata
Ferentino, Italia

2 settimane fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione
Our site in Ferentino is part of Pharma Services of Thermo Fisher Scientific.

We are looking for a talent in Regulatory Affairs Lead for our complex and highly regulated environment within the DPD sterile business unit.


RESPONSIBILITIES:


Regulatory CMC Services:

  • Assist in quotations preparation and enable proposal at different stages:
  • Evaluate regulatory feasibility and provide insight to clients screening;
  • Provide innovative pathway and spell out key regulatory deliverables for detailed proposal to enable quotations for Clients through product lifecycle from R&D, preclinical, clinical to commercial and post approval changes.
  • Promote CTD M3-Quality/CMC regulatory services offering and associated revenue generation:
  • Act as a facilitator with Clients for regulatory solving problems;
  • Counsel on regulatory matters and define strategies per latest standards.
  • Be accountable for yearly assigned regulatory revenue target, supervise invoices through revenue recognition in relation with Finance.

Regulatory Intelligence:

  • Monitor, anticipate, preevaluate and communicate on major regulations impacting the Drug Product aseptic manufacturing business:
  • Participate pro-actively to industry working groups to anticipate regulations development and facilitate implementation;
  • Provide SME consultation to organization.
  • Ensure domestic regulatory knowledge enhancement:
  • Enable access to regulatory update to the RA team and to the organization in a timely manner by disseminating information via adequate means;
  • Develop forums & trainings to key partners (Quality, BD etc.).

Regulatory Compliance:

  • Establish and maintain the regulatory compliance systems and serve as regulatory gateway for site between external and internal regulatory interactions:
  • Site compliance:
  • Setup & maintain data bases to capture site licensing material (SMF +/ foreign accreditations inclusive);
  • Build flawless connection with QA Compliance team for site compliance related regulatory update, to enable QA Compliance team to do gap analysis and/or comments feedback.
  • Product compliance:
  • Setup & maintain Clients' CMC files data base to ensure compliance with production and control master documents and enable product related regulatory gap analysis and or comments feedback;
  • Provide input on Change Controls initiated by the site or the Clients, and on deviation and investigation as well.
  • Be the point of contact for external parties/agencies for regulatory requirements comments feedback and any consultation for regulatory interpretation;
  • Sponsor Regulatory Compliance optimizations relevant to site and product conformance:
  • Develop and/or implement regulatory compliance initiatives: define work plan to fulfill the gaps, follow-up on implementation, sustain life-cycle management activities;
  • Establish site compliance indicators and report performance within set regional schedule.

REQUIREMENT

Education:


  • Bachelor's degree in Life Science (ex: Pharmaceutics, Chemistry, Microbiology, Chemical Engineering) or higher.

Experience:


  • Minimum 10 years of proven experience within regulatory affairs in the sterile space, CTD Quality/CMC, and cGMP manufacturing operations.
  • Familiar with sterile regulatory requirements (EMA, FDA, ICH) throughout the product life cycle, CMC development, preclinical to commercial etc.
  • Demonstrated ability to successfully mentor junior colleagues.

Competencies:


  • Intimate knowledge of USA, EU regulatory landscape (including GMP essentials) and exposure to professional communities such as PDA, TOPRA etc.
  • Experience with international regulations in APAC, LATAM and/or EEMEA.
  • Ability to evaluate and resolve regulatory and technical challenges.
  • Negotiation and influencing skills.
  • Entrepreneurial attitude and customercentric intuition for business.
  • Appropriate intelligentrisktaking mentality.
  • Ability to prioritize workload to meet timelines.
  • Sophisticated interpersonal skills, with ability to multitask and prioritize according to business need.
  • Effective communication skills.
  • Sound skills in typical office electronic platforms and IT agility.

Languages:


  • Italian and English.
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