Use Your Power for Purpose
We're committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer's medicines and vaccines. Your role will be essential in ensuring that our regulatory submissions are prepared, published, tracked, and quality-controlled to meet the highest standards, ultimately supporting patients globally.
What You Will Achieve
In this role, you will:
Provide operational support within the team to execute designated tasks associated with submission coordination activities for assigned products and/or at required dossier execution process workflow as appropriate.
Accountable for delivering designated tasks with quality and timely as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement.
Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
Escalate, inform, and/or resolve any issues that may impact timeline, quality, or compliance of submissions.
Commit to completing required on-the-job training courses to ensure training compliance is preserved.
Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components. Commit to completing required on-the-job training courses and Curriculum to ensure compliance is preserved.
Execute regional specific tasks to support on time project delivery.
Able to operate at pace with agile decision-making skills. Uses evidence and applies judgment to balance pace, rigour, and risk.
Here Is What You Need (Minimum Requirements)
B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
Proven technical aptitude and ability to quickly learn regional regulations, quality standards and use of new software,”
Advance to Fluent English language required
Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
Bonus Points If You Have (Preferred Requirements)
1 year of experience in similar positions
Ability to communicate information and analyses to a variety of audiences both verbal and written.
Use established procedures, with ability to quickly learn & apply the technical skills to achieve designated tasks
Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers.
Contributes to the completion of project tasks influencing the immediate work team.
Makes decisions from limited options to resolve basic problems with limited effect on projects Exercises judgment under significant supervision in a structured environment.
Agile Mindset
Strong attention to detail and analytical skills.
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs#LI-PFE