Regulatory Advisor - maternity leave replacement

at  Pfizer

Pfizer is hiring an enthusiastic Regulatory Affairs Advisor for the Global Regulatory Strategy (GRS) - Site of Rome for a maternity leave replacement.

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.
• 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 Head of Regulatory Affairs, Regulatory Affairs Manager /Sr. 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.
• Preparation and submission to AIFA of all MA variations (Labelling and CMC variations) and MA renewal applications in accordance to the requested timelines.
• 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.
• 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.
• Utilise local knowledge of Regulatory Authority’s expectations, ways of working etc. to appropriately direct company strategy. Share updates with colleagues.
• 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 years industry experience in Regulatory Affairs
• General 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: Fixed Term – maternity leave replacement
• Location: Rome
• Relocation Package Available: No
• Flexible working

Last day to apply: April 30th 2024
Purpose
Breakthroughs that change patients’ lives… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Regulatory Affairs

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 Head of Regulatory Affairs, Regulatory Affairs Manager /Sr. Manage

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.
• Preparation and submission to AIFA of all MA variations (Labelling and CMC variations) and MA renewal applications in accordance to the requested timelines.
• 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.
• 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.
• Utilise local knowledge of Regulatory Authority’s expectations, ways of working etc. to appropriately direct company strategy. Share updates with colleagues.
• 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