Key contributor in Integrated Resource Planning at Duke Energy. Prepare executives for regulatory testimonies on future energy demands and regulatory compliance.
About the role
- Global Regulatory Affairs CMC Lead driving regulatory strategies for pharmaceutical products and vaccines. Collaborating with cross-functional teams to navigate regulatory landscapes and influence drug approvals.
Responsibilities
- develop and implement global regulatory CMC strategies
- create strategies for development and marketed products
- focus on chemical entities, biological entities, and/or vaccine products
- execute and adapt strategies as needed
- serve as the primary point of contact for regulatory authorities
- act as direct liaison with agencies like US FDA and EMA
- develop positive relationships with regulators
- support strategic negotiations with worldwide Regulatory Health Authorities
- manage CMC documentation and submissions
- write, prepare, review, and approve regulatory CMC dossiers
- ensure dossiers meet quality standards
- comply with regulatory requirements
- maintain documentation accuracy and completeness
- lead cross-functional collaboration
- work closely with R&D Functions
- collaborate with Manufacturing & Supply Functions
- coordinate with GRA Regulatory Operations
- ensure effective implementation of regulatory strategies
- facilitate resolution of CMC issues
- identify and manage regulatory risks
- assess regulatory CMC opportunities and risks
- develop risk mitigation strategies
- communicate implications to project teams
- articulate risk/benefit components to stakeholders
- contribute to regulatory science and policy activities
- monitor local and international Health Authority regulations and guidelines
- participate in the review process for new regulations
- anticipate potential regulatory paradigm shifts
- track and communicate current Health Authority thinking and trends
Requirements
- 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
- experience responding to Health Authority questions
- experience preparing regulatory documentation and familiarity with standard submission processes
- understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets
- ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams
- Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field)
- strong written and verbal communication skills, with fluency in English
- capability to manage multiple projects in a fast-paced, hybrid work environment
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
- structured career paths for advancement
- flexible working options
- comprehensive well-being programs
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