Job Description

Committed to quality and excellence in compliance and conformance
\xef\x82\xb7 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.
\xef\x82\xb7 Ensures timely communication of any issues e.g. Board of Health queries to the regional teams as needed
\xef\x82\xb7 Manages multiple regions/projects/timelines of moderate complexity within a Work Team.
\xef\x82\xb7 Manages workload within the team for business continuity
\xef\x82\xb7 Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory
submission process.
\xef\x82\xb7 Responsible for evaluation of all CMC notifications for accuracy.
\xef\x82\xb7 Responsible for making updates in PDM Market Views for all submission types upon receipt of notification of
Submission and Approval evidence
\xef\x82\xb7 Applies technical knowledge and key concepts in PDM Conformance updates. Considered as a technical resource
within the work team.
\xef\x82\xb7 Demonstrates strong technical/functional knowledge w.r.t Regulatory requirements and internal process to coach
direct reports on day-to-day activities
\xef\x82\xb7 Breadth of technical/functional expertise is focused on applicable discipline
\xef\x82\xb7 Acts as a mentor for the colleagues
\xef\x82\xb7 Actively shares knowledge with others within Work Team through existing knowledge sharing processes/systems.
\xef\x82\xb7 Solves moderately complex problems within area of expertise
\xef\x82\xb7 Demonstrates effective written and oral communication skills
\xef\x82\xb7 Support for updates in PDM for License withdrawals
\xef\x82\xb7 Operate to the highest conformance and quality standards
\xef\x82\xb7 Operate in line with internal SOPs and policies
\xef\x82\xb7 Encourages the participation and perspectives of all Work Team\'s members
\xef\x82\xb7 Supports developmental and training opportunities for mentees
\xef\x82\xb7 Adhere to standard turnaround timelines
\xef\x82\xb7 Escalate any potential compliance issues to management

Liaise with regulatory colleagues to communicate and resolve potential issues
\xef\x82\xb7 Provide input to continuously improve and streamline the process
\xef\x82\xb7 Support periodic and ad-hoc system reports to estimate metrics
\xef\x82\xb7 Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention
\xef\x82\xb7 Assist in ensuring internal regulatory processes and procedures are well documented.
\xef\x82\xb7 Assist in remediation activities.

1. Technical Skills -
\xef\x82\xb7 Knowledge and / or experience in pharmaceutical industry in Regulatory / Quality Assurance,
especially in Life cycle management or compliance.
\xef\x82\xb7 Strong quality and compliance orientation
\xef\x82\xb7 Diligence and attention to detail
\xef\x82\xb7 Prior Regulatory experience in any of the market
\xef\x82\xb7 Knowledge of regulatory practices, rules, regulations and guidelines
\xef\x82\xb7 Good communication skills
\xef\x82\xb7 Problem Solving
\xef\x82\xb7 Understanding stakeholder needs.
\xef\x82\xb7 Fluent English Speaker
2. Standards, Processes and Policies - General standards, processes and policies of Pfizer/Pharmaceutical
manufacturing
3. Behavioral/Any other Skills \xe2\x80\x93 An assertive, take-charge, results oriented, positive \xe2\x80\x9ccan do\xe2\x80\x9d attitude, and a
sense of urgency doing things done.
4. Preferred Qualification \xe2\x80\x93 Master\xe2\x80\x99s / Bachelor\xe2\x80\x99s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a
related life sciences.
5. Preferred Year Of Experience - 10 to 14 years of experience in a quality or compliance role within the pharmaceutical industry
6. Type of Experience - 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.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

#LI-PFE

Pfizer