Manager, Regional Regulatory Strategist – Global Brands
Pfizer
full-time
Posted on:
Location Type: Office
Location: Warsaw • 🇵🇱 Poland
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Represent a particular region for regulatory affairs (US, EU or EM)
- Provide regional regulatory strategies in agreement with stakeholders
- Accountable for timely submissions and approvals with commercially attractive labelling
- Engage with Health Authorities regarding assigned project(s)
- Monitor regulatory plans and progress to communicate to GRL and Senior Management
- Develop relationships with Health Authority contacts
- Support operational activities including submissions and responses to queries
Requirements
- BS/BA (Pharmacy, Chemistry, Biology, or related science) with 5+ years of related technical experience
- Proven experience in managing national and/or regional regulatory process
- Previous experience as a national and/or regional regulatory liaison
- Experience communicating with FDA or major EU regulatory agency
- Familiarity with drug development practice rules, regulations and guidelines
- Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs
- Ability to communicate complex information and analyses in English
- Presentation skills in different settings
- Negotiation skills in tough situations
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategiessubmissionsapprovalsINDsCTAsNDAsMAAIRDsdrug development regulationstechnical experience
Soft skills
communicationpresentation skillsnegotiation skillsrelationship buildingstakeholder engagementmonitoring progressaccountabilitycomplex information analysistimely reportingoperational support
Certifications
BS/BA in PharmacyBS/BA in ChemistryBS/BA in Biologyrelated science degree