Senior Associate, ESOQ Regulatory Operations

1 week ago

Makati City, National Capital Region, Philippines Pfizer Full time ₱1,500,000 - ₱3,000,000 per year

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

  • Senior Associate, ESOQ Regulatory Operations

    1 week ago

    Makati City, National Capital Region, Philippines Pfizer Full time ₱1,500,000 - ₱3,000,000 per year

    Why Patients Need YouOur 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...

  • Regulatory Affairs Associate

    1 day ago

    Makati City, National Capital Region, Philippines Transmedic Group Full time ₱120,000 - ₱180,000 per year

    Main FunctionA Regulatory Affairs Associate is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under government regulations and ensure compliance of the company to Quality Safe Health and Environment policies and...

  • Regulatory Compliance Manager

    1 week ago

    Makati City, National Capital Region, Philippines The Bistro Group Full time ₱1,500,000 - ₱2,500,000 per year

    Job DescriptionPosition OverviewThe Regulatory & Compliance Manager is responsible for ensuring that The Bistro Group operates in full compliance with applicable laws, regulations, and industry standards. This role manages regulatory relationships, oversees compliance programs, and supports strategic initiatives to mitigate legal and operational risks. The...

  • Associate Director – Regulatory Remediation

    1 day ago

    Quezon City, National Capital Region, Philippines Aumtrend Full time ₱1,440,000 - ₱2,400,000 per year

    Role : . Associate Director – Regulatory Remediation & ControlsCompany : One of the global client -Insurance companyLocation : Quezon city - UP TechnoHub & CEBUWork Setup : Hybrid - 3 days onsite/weekSchedule: Flexible, Mid Shift, some overlap with night shift schedulesPermanent position & Direct Hiring by the clientRequired Technical Skill Set :Focus:...

  • Associate Director, ​Regulatory Remediation and Controls

    1 day ago

    Quezon City, National Capital Region, Philippines John Clements Consultants, Inc. Full time ₱1,500,000 - ₱2,500,000 per year

    As an Associate Director, ​Regulatory Remediation and Controls,you are expected to provide strategic leadership and oversight to a high-performing team, collaborate with senior leadership to execute strategic initiatives, influence policy optimization, and maintain a proactive regulatory posture through internal audits and control testing. Additionally,...

  • Senior Associate

    1 day ago

    Makati City, National Capital Region, Philippines HC Global Fund Services, LLC Full time ₱900,000 - ₱1,200,000 per year

    About UsHC Global Fund Services, LLC ("HC Global") is a privately owned fund administrator serving fund managers and investment advisors in the alternative investments industry.Job DescriptionAs Senior Associate, you will be responsible for such duties and responsibilities that are normally associated with your position, which include, but are not limited to...

  • Senior Associate, Market Strategy

    2 weeks ago

    Makati City, National Capital Region, Philippines ACEN Full time ₱1,500,000 - ₱2,500,000 per year

    Education Requirement:Bachelor's degree in business, Economics, Engineering, or a related fieldTechnical Knowledge, Special Trainings and Work ExperienceHas experience working in the Philippine energy industry and are familiar with the overall industry history, structure, regulatory environment, and key market participants (e.g., generation companies, ERC,...

  • Associate Director, Regulatory Governance

    2 weeks ago

    Quezon City, National Capital Region, Philippines Manulife Full time ₱2,500,000 - ₱6,000,000 per year

    We ' re looking for an Associate Director, Regulatory Governance to join our ICS team at MBPS. In this role, you are involved in providing strategic leadership and oversight for regulatory transformation initiatives, ensuring alignment with business objectives and enhancing compliance practices through innovation and data-driven strategies. This position...

  • Associate Director, Regulatory Remediation and Controls

    2 weeks ago

    Quezon City, National Capital Region, Philippines Manulife Full time ₱2,500,000 - ₱6,000,000 per year

    We ' re looking for an Associate Director,Regulatory Remediation and Controls to join our ICS team at MBPS. In this role, you are expected to provide strategic leadership and oversight to a high-performing team, collaborate with senior leadership to execute strategic initiatives, influence policy optimization, and maintain a proactive regulatory posture...

  • Associate Director – Regulatory Transformation

    1 day ago

    Quezon City, National Capital Region, Philippines Aumtrend Full time ₱1,500,000 - ₱3,000,000 per year

    Role : 2. Associate Director – Regulatory Transformation & GovernanceCompany : One of the global client -Insurance companyLocation : Quezon city - UP TechnoHub & CEBUWork Setup : Hybrid - 3 days onsite/weekSchedule: Flexible, Mid Shift, some overlap with night shift schedulesPermanent position & Direct Hiring by the clientRequired Technical Skill Set...