Pfizer Healthcare Hiring for Regulatory Affairs Department

• Committed to quality and excellence in compliance and conformance
• Accountable for maintaining the corporate change and dossier management system (PDM) regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and policies.
• Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.

JOB RESPONSIBILITIES :

• Committed to quality and excellence in compliance and conformance
• Accountable for maintaining the corporate change and dossier management system (PDM) with respect to the HA status of regulatory CMC submissions with global health authorities per internal SOPs and policies.
• Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.
• Responsible for making independent updates in PDM Market Views for all the allotted notifications
• Applies technical knowledge and key concepts in PDM Conformance updates. Considered as a technical resource within the work team.
• Demonstrates good technical/functional knowledge w.r.t Regulatory requirements and internal process

Manages own work independently and guides direct reports on day-to-day activities

• Solves moderately complex problems within area of expertise
• Has good understanding on CMC-LCM related regulations to collaborate with the GRA colleagues in addressing the complex updates
• Ensures the performance metrics of self and the direct report is maintained always
• Reiews the performance of the direct reports on periodic basis updates the Manager about the Goal progress/gaps etc.
• Shares constructive feedback to direct reports as necessary
• Ensure timely completion of QC checks of the updates performed by collegues within the team and shares timely feedback in systematic way for the improvement areas
• Supports with periodic reports to estimate metrics
• Operate to the highest conformance and quality standards
• Adhere to standard turnaround timelines for self and the direct reports
• Always alert in providing input for continuous improvement and streamline the process
• Supports developmental and training opportunities for direct reports and manages the performance of direct reports
• Escalate any potential compliance issues appropriately
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
• Assist in ensuring internal regulatory processes and procedures are well documented
• Assist in remediation activities as necessary
• With good understanding on relevant regional regulations and CMC experience, acts as SME for Regions
• Manages workload within the team for business continuity
• Has good understanding on the tools and compliance aspects
• Acts as a mentor for the colleagues
• Esnures compliance on trainings and other demands for self and direct reports
• Ensures periodic on-job referesher trainings are arranged in collaboration with respective SMEs

Technical Skills –

• Knowledge and / or experience in Pharmaceutical Regulatory Affairs / Quality Assurance, especially in Life cycle management or compliance.
• Strong quality and compliance orientation
• Prior Regulatory experience in any of the market
• Knowledge of regulatory practices, rules, regulations and guidelines
• Good communication skills
• Problem Solving
• Understanding stakeholder needs

Standards, Processes and Policies –

• General standards, processes and policies of Pfizer/Pharmaceutical manufacturing

Behavioral/Any other Skills –

An assertive, take-charge, results oriented, positive can do attitude, and a sense of urgency doing things done.

Preferred Qualification

– Master s / Bachelor s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.

Preferred Year Of Experience – 7 to 14 years

Type of Experience – Experience in a quality or compliance role within the pharmaceutical industry Demonstrated regulatory or quality experience within a pharmaceutical company with proven examples of contribution. Proven ability to consistently deliver to high quality standards and timelines. Proven ability to successfully operate in a cross functional environment

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