Job DescriptionJoin Our Team as a Regulatory Affairs Specialist!Are you ready to make a difference in the world of healthcare? At Pfizer, we are dedicated to transforming patients' lives through innovative solutions. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring our products meet the highest standards of safety and efficacy. Join us in our mission to create breakthroughs that change lives!
Job Responsibilities
- Deliver Regulatory Strategy: Collaborate with cross-functional teams to provide expert regulatory advice and information.
- Manage Applications: Oversee New Registration, Marketing Authorization (MA) Variation, and MA Renewal Applications.
- Engage with Authorities: Respond promptly to queries from National Regulatory Authorities (NRA) and seek clarification when needed.
- Support Clinical Development: Partner with national Regulatory Authorities and Clinical Trials Regulatory Strategy Execution (CTRSE) to support strategic clinical activities.
- Maintain Regulatory Databases: Ensure accurate and up-to-date records of regulatory activities.
- Safeguard Compliance: Manage updates to packaging and prescribing information components.
- Contribute to Good Regulatory Practice: Support the development of regulatory best practices within the team.
- Lead Personal Development: Take charge of your growth and development in the regulatory field.
Qualifications & Skills
- Educational Background: Life sciences or chemistry graduate to honors level or equivalent; Master's degree, Post Graduate Diploma, or PhD preferred.
- Professional Qualifications: Relevant qualifications such as an MSc in Regulatory Affairs are desirable.
- Experience: Proven track record in Regulatory Affairs for Human Medicinal Products.
- Technical Skills: Strong computer literacy and excellent written and verbal communication skills.
- Analytical Thinking: Demonstrated strength in analytical problem-solving.
Working Conditions
All applicants must have the relevant authorization to live and work in UK. We foster a trusting and flexible workplace culture that encourages work-life harmony, allowing you to be your best self.
Why Join Pfizer?
- Growth Opportunities: We are committed to your professional development and offer various pathways for growth.
- Diversity & Inclusion: We celebrate a diverse workforce and believe it is crucial to our success. Join a culture that empowers everyone.
- Disability Confident Employer: We are proud to support individuals with unique abilities and will make reasonable adjustments to support your journey with us.
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Senior Regulatory Associate in Tadworth employer: Pfizer Inc.
At Pfizer, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. As the CQ International Markets Team Lead, you will have the opportunity to lead a talented team while driving strategic initiatives that enhance quality and compliance across our global operations. With a strong focus on employee development, we provide ample growth opportunities and encourage the adoption of cutting-edge technologies, ensuring that our workforce is equipped to thrive in a rapidly evolving industry.
