Jr Associate Reg Cmc Strategy

2 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

As Junior colleague you will assist CMC professionals with the development of chemistry, manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals 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 in a position to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.

As a junior colleague your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

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

How You Will Achieve It
- Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects within a work team.
- Support the assembly of Chemistry Manufacturing and Control (CMC) information for submission to global regulatory agencies and supports CMC strategies with supervision.
- Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.
- Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
- Responsible for the preparation and finalization of Global Regulatory Strategy Documents, Clinical Data Request (CTD) sections of supplements or variations for site transfer submissions.
- Recommend solutions and escalates issues with significant business impact.
- Manage projects independently, make decisions and execute upon strategies and plans with mínimal oversight from manager.

**Qualifications**:
Must-Have- Basic Qualifications
- Bachelor’s degree in a science-related field, Pharmacy, CTF or equivalent (healthcare professional qualification preferred).
- Experience in regulatory, or in clinical or scientific research is an advantage but not a requirement.
- Due to the international environment, fluent English in comprehension, reading and speaking skills (C1 o higher) is a requirement.
- Microsoft Office competent user (mainly Word, PowerPoint, Excel).

Furthermore, you are a young minded, practical person with hands-on mentality, good planning skills with orientation to project, compliance and deadlines, consistency and pro-active approach, effective process analytical skills. Accustomed to working under pressure due to business needs, when required.
- You feel comfortable to make basic decisions with an understanding of the consequences. You have good interpersonal skills to work with multi-cultural colleagues and good motivational skills (results driven). High sense of duty.

Nice-to-Have- Post-Graduate Master in Regulatory Affairs- Relevant pharmaceutical experience- Experience managing projects

LI-PFE

Permanent Contract

Location: Milan (flexible working)

Please send resume in English.
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 pati

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