Senior Associate, ESOQ Regulatory Operations

Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
You will be a member of Pfizer's dedicated and highly effective Quality Assurance and Control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. You will be accountable for assessing the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.
You will be known to be team player, who is able to achieve targets on time. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues. 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

• Support Post Approval Changes, initial registrations and/or renewals
• Act as a regulatory expert, advising of regulatory strategy and potential supply constraints, if applicable
• Act as a liaison between CMOs and internal Pfizer functions to ensure timely progression of regulatory activities
• Monitor and notify regulatory submission status, BOH queries, commitments, and approvals
• Support in Compliance Assessment and New Regulations/compendia requirements implementation as required
• Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, BOH queries, and regulatory commitments
• Support license renewals (e.g. GMP Clearance) and Tender applications
• Manage routine complaints for commercial drug product and medical device and combination product
• Verify and approve all quality related fields involved in the creation, change, and extension workflows at the Enterprise and Plant Operations levels in SAP

Qualifications
Must-Have

• Minimally 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Master's degree).
• Expertise in Change Management and/or Regulatory.
• Experience with relevant QTS & eQMS modules.
• Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices.
• Is diplomatic, clear & succinct in communication with internal and external stakeholders.
• Committed to the Change Management Best Practices to enable improvement of the Change Management Process and System.
• Embraces innovation and change to find solutions.
• Collaborative and embraces Pfizer mindset: Courage, Equity, Excellence, Joy.
• Proficient in English and technical writing.
• Good interpersonal and influential skills.
• Good verbal & written skills. Demonstrated success leading Projects.
• Decision-making based on a science-based risk approach.
• Ability to work with minimal supervision in a global organization.

Work Location Assignment: Hybrid
Regular Permanent, Full time position
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control