Manager Regulatory Cmc Strategy

3 settimane fa

Milano, Italia Pfizer A tempo pieno

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will help Pfizer develop and implement chemistry, manufacturing, and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and devices to meet global regulatory requirements throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing, or authoring CMC regulatory investigational, commercial and post approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, manages regulatory documents, etc. You will also be able to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.

As a manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts, and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Serve as a CMC strategist and project leader for projects within the Global Pfizer Biopharmaceuticals Group Hospital and Brands Category portfolio, providing initial regulatory assessments and developing regulatory strategies with appropriate supervision.

Act as the global CMC representative, or contributes support to the global CMC representative, within cross-functional project teams, including Pharmaceutical Sciences and Co-Development teams. Accountable for assigned projects and activities, completing work within assigned product portfolio, work group/project teams, for multiple projects with supervision.

Interpret CMC regulatory requirements for human health prescription products, develops initial strategies, assess risks, and develops contingency proposals with appropriate supervision. Uses technical and scientific knowledge to conduct the initial analysis of CMC submission documentation. Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.

Responsible for the authoring of CMC documentation, coordination, and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.

Ability to collaborate effectively across a network of other stakeholders, partners, and customers, to deliver high quality CMC submissions and ensuring the compliance of the Pfizer essential pharma therapeutic portfolio. Develops initial resolution proposals for regulatory CMC/information management issues with project/program stakeholders. Displays a willingness to make decisions with appropriate input from leadership, exhibits sound and accurate judgment and makes timely decisions.

Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives with mínimal supervision.

**Qualifications**:
Must-Have- Bachelor's Degree plus 5+ years of experience- Relevant pharmaceutical development, Quality Assurance/ Quality Control (QA/QC), and/or manufacturing experience- Minimum of 2-3 years drug substance or drug product development or manufacturing technical support experience.- Fluent in Italian and English- Experience with diverse dosage forms is desirable.- A regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain.- Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems.- Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.Nice-to-Have- Master's degree plus 3 years' experience- Relevant pharmaceutical experience- Experience in CMC supporting clinical and post approval programs with diverse dosage formulations is desirable.

Deadline to apply: Feb 21, 2023
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 ou

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