Manager, Regulatory Quality – Vaccines

🔥 2 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $88.5k - $147.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💰 Post-IPO Debt on 2023-05

We’re celebrating 175 years of daring scientific innovation—and we’re not done yet. Every day, we’re channeling our passion and resources into delivering innovative therapies that change the face of healthcare. Let’s outdo yesterday.

📋 Description

• Support projects of all levels of complexity and take joint accountability for deliverables, or lead less complex projects/workstreams within the department. • Partner closely with cross-functional stakeholders to drive execution of deliverables. • Ensure project compliance with global regulatory standards. • Ensure regulatory deliverables are completed on time, in compliance with current regulatory guidance, and in full submission-ready format. • Perform submission-ready quality review and ensure documents align with regulatory guidance and internal standards. • Independently execute assigned tasks and deliverables, making data-informed decisions. • Explore and propose ideas for process improvements within existing SOPs and guidance documents. • Foster a culture of innovation by developing scientific activities that support strategic goals. • Identify and address interpersonal or process conflicts within the immediate team.

🎯 Requirements

• BA/BS with at least 4 years of experience, an MBA/MS with at least 2 years of experience. • Extensive knowledge of regulatory and quality assurance in the pharmaceutical or vaccine industry. • Strong understanding of global regulatory requirements and guidelines. • Proven track record in project management within a regulatory or scientific setting. • Experience in reviewing regulatory documentation. • Ability to analyze and interpret scientific data to support regulatory submissions. • Proficient in risk assessment and mitigation strategies related to vaccine development. • Familiarity with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) • Excellent organizational skills and attention to detail. • Proficiency with document authoring and review tools (e.g., Microsoft Word advanced features) and regulated document management systems.

🏖️ Benefits

• 401(k) plan with Pfizer Matching Contributions • Additional Pfizer Retirement Savings Contribution • Paid vacation • Holiday and personal days • Paid caregiver/parental and medical leave • Health benefits including medical, prescription drug, dental and vision coverage