Manager, Regional Regulatory Strategist – Global Brands
Pfizer
Senior Associate, Regional Regulatory Strategist – Global Brands
Pfizer
full-time
Posted on:
Location Type: Office
Location: Warsaw • 🇵🇱 Poland
Visit company websiteJob Level
Senior
About the role
- Develop and implement European and US regulatory strategy aligned with business needs
- Support key regulatory tasks across programs and disease areas
- Ensure timely planning, preparation, submissions and approvals of program deliverables
- Collaborate with project teams to meet regulatory needs and objectives
- Manage regulatory contributions and compliance in assigned region
Requirements
- Bachelor’s degree in a scientific field required
- Minimum of 2 years of experience
- Knowledge of drug development practice rules, regulations and guidelines
- Basic understanding of regulatory agency philosophy and guidelines
- Experience with preparing and submitting NDAs / MAA/IRDs desirable
- Communication skills for complex information delivery
- Effective presentation skills
- Strong negotiation skills for internal and external groups
Benefits
- Health insurance
- Employee development programs
- Flexible working environment
- Inclusive company culture
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentregulatory complianceNDA preparationMAA preparationIRD preparationdrug development regulationsregulatory guidelines
Soft skills
communication skillspresentation skillsnegotiation skillscollaboration
Certifications
Bachelor’s degree