Regulatory Compliance Officer at Transport for NSW conducting investigations and audits for third party programs. Ensuring compliance with regulatory schemes and engaging with relevant programme participants.
About the role
- Accountable for leading a global team of data stewards in Regulatory International Operations. Ensuring the accuracy and integrity of Pfizer’s master & registration data for clinical & commercial portfolio.
Responsibilities
- Maintains overall accountability for the accuracy and compliance of product master and event data.
- Oversight and management of people, technical resources and budget associated with TA aligned Regulatory Data Vanguard.
- Foster strong working relationships with GRS and CMC LT leaders.
- Lead Team delivering end to end data management and process execution.
- Demonstrate comprehensive knowledge of the Regulatory Continuum and Vault RIM functionality.
- Play a leading role in the continued harmonisation of data standards.
- Ensure all in scope activities are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
Requirements
- Bachelor’s or Master’s degree, preferably in Life Sciences, Regulatory Affairs, Data Management, or related field.
- 8+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 2 years in a data governance, data management, or data quality/compliance role.
- 3+ years management & supervisory experience in a regulatory field managing global and/or local resources & resource capacity algorithms.
- Fluent in English.
- Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment.
- Detailed understanding of regulatory system structures.
Benefits
- Health benefits to include medical, prescription drug, dental and vision coverage.
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Eligibility to participate in Pfizer’s Global Performance Plan with a bonus target of 20.0% of base salary.
- Participation in share based long term incentive program
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