Manager, Regulatory Affairs
1 settimana fa
**JOB SUMMARY**:
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 life-cycle from R&D, pre-clinical, 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, pre-evaluate 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:
- Set-up & 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:
- Set-up & 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, pre-clinical 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 customer-centric intuition for business.
- Appropriate intelligent-risk-taking mentality.
- Ability to prioritize workload to meet timelines.
- Sophisticated interpersonal skills, with ability to multi-task 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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