Regulatory Affairs Advisor Lazio

Regulatory Affairs Advisor
Roma
Lazio, Lazio

Pfizer is hiring an enthusiastic Regulatory Affairs Advisor for the Global Regulatory Affairs (GRA) International - Site of Rome.

Why Patients Need You- Maintain product registration, via management of regulatory activities and projects related to products under his/her responsibility.

Keep products on the market and avoid shortages in order to keep products available to patients. - Submission of Marketing Authorisation Applications (MAA) and product authorisation maintenance activities; submission of Clinical Trial Applications (CTAs) and subsequent amendments to the National Competent Authority (NCA). - Ensure all activities are carried out in compliance with Pfizer SOPs and systems, Regulatory requirements and Ethical codes.

Key Experience Offer of this Role- Manage assigned products (NP, MRP/DCP, CP) lifecycle and related projects.

All activities carried out in compliance with Pfizer SOPs and systems, Regulatory requirements and Ethical codes. - Participates in local cross functional teams for assets under his/her responsibility.

Interacts with corresponding above country strategists and functional hubs as appropriate.

Interacts with AIFA assessors as appropriate. - Reports to the Regulatory Affairs Manager.

Primary Responsibilities- Preparation and submission to AIFA (Italian Drug Regulatory Agency) of registration packages for new MA submissions or line extensions according to MRP/DCP or National procedures; preparation and/or review of Italian translations for CPs, and any relevant activities. -

- Ensure maintenance, regulatory compliance (quality, safety and efficacy) and life cycle optimization of all Pfizer authorised products under his/her responsibility in line with internal SOPs in force.

All reg.

activities related to products under his/her responsibility carried out and tracked on a timely manner. - Respond to requests from AIFA promptly and accurately, in line with internal SOPs. - Ensure timely communication of any GCP breaches, or actions taken for safety reasons. - Liaise with clinical research project managers to seek to understand clinical research programme. -

- Maintain current mandatory databases and document management systems in line with internal SOPs in force. - Ensures full compliance/inspection-audit readiness as established by internal SOPs. - Completes mandatory training within defined timelines. - Ensure notifications of proposed regulatory changes and approvals are provided to relevant stakeholders in a timely manner. - Actively contribute to implement effective and efficient processes. - Participate as required in cross-functional project teams, to address business needs in line with business objectives and strategic imperatives. - Input to the local and international Pfizer strategic planning process as appropriate, and participate to the above-country projects such as Label as a Driver (LAD), pilot projects, limited-duration teams, etc. - Participate as SME to above country RA projects. - Utilise local knowledge of Regulatory Authority's expectations, ways of working etc.

to appropriately direct company strategy.

Share updates with colleagues. - Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network. - Develop and enhance working relationships with Regulatory Authority.

Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.

And work with authorities if Pfizer position differs from authority position in order to obtain a better outcome for the business/patients.

What You Offer- Bachelor degree or higher in science or health related field, Pharmacy or Chemistry and Pharmaceutical Technology (CTF) are preferred. - 3 to 5 years industry experience in Regulatory Affairs. - Knowledge in the EU and Italian Regulation in the pharmaceutical sector. - Fluent knowledge in English and good knowledge of Windows and Microsoft Office. - Knowledge of the European and Global regulatory environment and how this impacts regulatory strategy and implementation. - Knowledge of drug development practice, rules, regulations and guidelines. - Analytical Thinker- Understanding stakeholder needs- Team working, Strong quality and compliance orientation, Priority setting and time management capabilities- Adaptability, Driving for results, Personal learning- Communications skills: Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message. - Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. - Problem Solving: Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed solutions.

Other Job Details

- Contract Type: Permanent

- Location: Rome

- Relocation Package Available: N

- Flexible working: based on company policy & business needs

Purpose

-Breakthroughs that change patien