Associate Manager I - Reg CMC Strategy (LEC Team)
- India - Chennai
- India - Pfizer Centre
JOBSUMMARY
Functions as a Strategist for Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and CrossFunctionalTeamstoprepareandsubmitthevariationsforentitynamechangeacrossglobalmarkets including US, EU & ROW as per defined timelines.
JOBRESPONSIBILITIES
· Managesday-to-dayregulatoryactivitiesassociatedwithassignedLECvariationswithinagreed upon timelines.
· Evaluate change controls for completeness, accuracy andrequiredsupporting documents.Initiate change controls when needed.
· PerformsMarketImpactAssessment(MIA)forthespecificentitynamechange.
· RunstheReg Atlastodeterminethefilingactionandimpactedsections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead.
· SearchRegulatorydatabasesforCommonTechnicalDocumentcomponentsorrequest themfrom appropriate market contacts, when not available.
· FamiliaritywithglobalguidelinesforfilingLegalEntityChanges(LEC)andruncorrespondingreports in the regulatory requirements database.
· Shouldbe familiarwithsubmissiongroupingpractices.
· Interpretandapplyglobal/regionalCMCregulatorypolicies.
· Requestdocumentsfromthesites/markets/centerfunctionsasneeded.
· RequestAncillarydocumentsfromAncillarydocumentsteam.
· Communicatewithmarketsifclarification/prioritizationisneeded.
· Followupwithallresponsibledisciplinestobeabletomeettimelines.
· AuthoringoftheimpactedCMCsectionsi.e.Module3undertheguidancefromthe product strategistsas appropriate and within agreed timelines.
· ResponsibleforobtainingapprovalinReg-459formfromGRS CMCsonthecompletionofauthoring the sections.
· UtilizesPfizer’s CMCsystems, i.e.GDMS,PDM,SPA, PEARL, RegAtlas, Rosetta etc.,as appropriate.
· MustbeextremelyorganizedasLEC projectscanrunacrossmultipleproducts/markets.
· EnsurescompliancetoPfizerinternalproceduresandtrainingSOPs.
· Ownership of process improvements, metrics and delivery risks
· Team player and work under matrix environment
· Works under the supervision of line manager
. Escalation management and cross-functional issue resolution.
· Accountability for defined team milestones, rather than only assigned individual activities.
· Technical coaching or knowledge sharing within the work team.
· Takesresponsibilityforaportionoftheworkteam’smilestones/ deliverables.
. Any other requests as assigned by line managers.
QUALIFICATIONS/SKILLS
PreferredEducation:
Minimum–Postgraduate inPharmacy
PreferredExperience:
Minimum 7YearsinleadingindependentlyintheRegulatory Sciencesfunctionina reputedPharmaceuticalOrganization.KnowledgeofNDAs,ANDAs,MAAs,CTDsandother regulatory components.
PreferredAttributes:
ExcellentoralandwrittenEnglishcommunicationskills.Goodconceptual,analytical,problemsolving, reasoning and organizational skills. Should be change agile, prioritization of projects with minimum guidance. Attention to detail and accuracy required.
TechnicalSkills:
Regulatory requirementsofpostapprovalchangesforUS,EUandROWmarkets.
OralSolidDosageformandsterileinjectablemanufacturingandregulatorydatarequirementsfor post approval submissions.
Knowledgeinretrievinginformationfromcompany’sandregulatory agencydatabases.
Advanced levelofknowledgeongeneralstandards,processes,regulatoryguidancesandpoliciesof Pfizer/Pharmaceutical manufacturing Industry.
Remainknowledgeableaboutcurrentregulationsandguidance,interpretsandnotifies appropriate personnel.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Regulatory Affairs
Breakthroughs that change patients’ lives
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Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
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Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Pfizer Research & Development
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Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
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- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)