Senior QA Regulatory Specialist

This role is Site Compliance Network Member (SCNM) which is within the Quality function and is the liaison between the site and Regulatory CMC. The SCNM works collaboratively with site and Regulatory colleagues in the coordination of regulatory impacted change management activities to facilitate change and CMC related initiatives.

The essential responsibilities of the SCNM are, at a minimum:

• Collaborate with site representatives for market implementation strategies that meet regulatory compliance requirements for site related changes
• Support Post Approval Changes, initial registrations and/or renewals.
• Responsible for reviewing site change requests and assessing impact on external functions (i.e. center functions, artwork & labeling, multiple sites, regulatory affairs), as well as confirm requirement to present to Site Change Control Committee.
• Initiate global change management process when external impact is determined (i.e. Create global gQTS records, and act as principal Point of Contact/Responsible Person for global records).
• Initiate regulatory change management process when potential regulatory impact is determined (i.e. Create PCF and identify appropriate CMC Strategist, product codes and markets); Act as principal Point of Contact/Responsible Person for PCF).
• Monitor PCF status to determine implementation timeline.
• For multi-marketed products, oversee implementation strategy (in consultation with change Responsible Person), i.e. coordinate which markets can (or cannot) receive product.
• Provide data/documentation from other electronic systems as required to facilitate CMC strategist review of PCF (i.e. procedures, drawings, etc.).
• Function as Site Point of Contact between Site and Country organizations for regulatory matters (i.e. direct requests for regulatory support to the appropriate site representative/functional area; provide samples, Certificates of Analysis, related documentation for tender requests and product re-registration /renewals, etc.).
• Create monthly Market Authorization APQR sub-reports .
• Assure Company practices meet TGA, FDA, MHRA, EMA, Health Canada, cGMP and other regulations.
• Adhere to compliance plans aligned with company objectives both local and global and support local functions in achieving requirements.
• Engage in continuous improvement culture and activities within the department.

Qualifications:

A minimum Bachelor's Degree in an Engineering, Scientific or related discipline is required for this role.

Years of Experience: 3+ years, 1 of 2 years in Quality or Regulatory function.

The RSCNM must also at minimum demonstrate the following knowledge/skills:

• Knowledge of cGMP and Regulatory requirements for Australia, EMEA and USA.
• Work prioritization skills
• Ability to keep comprehensive and accurate records in a multi-faceted environment
• Well-developed written and verbal communication skills
• Well-developed consultation and negotiation skills

Proficient computer literacy

Work Location Assignment: On Premise

At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:

• Paid parental leave
• Access to Health & Wellness apps
• Career Growth Experiences program
• Recognition & rewards program
• Paid volunteer days
• Life Insurance Benefits
• Pfizer Learning Academy access to top content providers
• Access to flu vaccines & skin checks
• Options to purchase additional leave
• Salary packaging & novated lease options
• Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.

Regulatory Affairs