Regulatory Affairs Manager managing drug approval processes for a successful pharmaceutical company. Responsible for documentation submission and lifecycle management in compliance with regulations.
About the role
- Global IVD Regulatory Portfolio Manager overseeing oncology regulatory strategy initiatives. Collaborating with teams to support development and delivery of innovative medicines and diagnostics.
Responsibilities
- Oversee and manage initiatives within the IVD Regulatory Center of Excellence (COE)
- Support oncology regulatory strategy programs across the drug development lifecycle
- Collaborate with cross-functional teams and external partners
- Drive high-quality IVD co-development program timelines, dashboards, and tools
- Resolve project issues, guide operational teams, and facilitate agreements across the enterprise
Requirements
- Bachelor’s degree required; Master’s degree preferred
- Direct experience leading projects in a highly regulated environment
- Proven ability to manage multiple projects with competing deadlines
- Knowledge of IVD manufacturing and associated processes
- Excellent oral and written communication skills
- Proficiency with Microsoft applications
- Experience managing pharmaceutical, technical, IVD, or medical device projects and/or clinical programs (Nice-to-Have)
- Experience leading regulatory submissions for IVD and/or drug applications (Nice-to-Have)
- Experience with Microsoft Project or equivalent systems (Nice-to-Have)
- Certification in operational excellence methodologies (e.g., Six Sigma, Lean) (Nice-to-Have)
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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