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 effectiveQualityAssurance andControl 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.
• Review and assess the changes affecting our Third-Party Manufacturing Operations by performing regulatory impact assessment in collaboration with Regulatory Strategists as needed.
• Act as a liaison between CMOs, Virtual Site Operations Teams (VSOTs), Pfizer Global Supply (PGS) sites within the Global Chemistry, Manufacturing Compliance (CMC) organization, Regional Strategist (if required) or Pfizer Country Offices (PCO).
• Initiate Quality Tracking System (QTS) records (if identified as Change Owner), Post Approval Change (PAC) records and regulatory change control (PCF) for Third-Party Manufacturing Operations or Pfizer -initiated Post Approval Changes with potential regulatory impact.
• Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, and BOH queries from Third-Party Manufacturing Operations and PGS sites as required.
• Monitor and notify the Third-Party Manufacturing Operations and VSOT through the escalation process of regulatory submission status, BOH queries, commitments and approvals.
• Act as regulatory expert within the VSOT, advising of regulatory strategy and potential supply constraints, if applicable
• Act as regulatory expert for Third-Party Manufacturing Operations liaising with Pfizer Global Regulatory Science (GRS) and supporting systems (e.g. RRM, PEARL, GDMS etc.)
• Support in Compliance Assessment and New Regulations/compendia requirements implementation as required
• Manage routine complaints for commercial drug product and medical device and combination product
  
  

Qualifications

Must-Have

• Bachelor’s Degree and 2+ years of relevant experience
• Good knowledge of enterprise systems such as Product Dossier Manager (PDM), QTS Trackwise, Veeva Vault, Documentum platforms.
• Excellent leadership, presentation and oral/written communication skills
• Ability to build strong working relationships with leaders and cross-functional teams
  
  

Nice-to-Have

• Master's degree
• Experience in regulatory science, project management and manufacturing operations
• Demonstrated capability to work as a team member in a matrix environment
  
  

Work Location Assignment: Hybrid

Regular Permanent, Full time position

Work Location Assignment: Hybrid

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