Regulatory Affairs CMC Expert
hace 4 semanas
Position Overview
We are seeking a highly skilled professional in Regulatory Affairs to manage and enhance the CMC (Chemistry, Manufacturing and Control) documentation for designated products, including prescription and non-monograph over-the-counter medications.
This role involves the development of strategic regulatory CMC plans aimed at geographical expansion and post-approval CMC initiatives.
Core Responsibilities
- Contribute to the formulation of global regulatory CMC strategies.
- Evaluate the regulatory implications of proposed CMC modifications and assist in the development of regulatory strategies that facilitate the implementation of these changes.
- Review data submitted for dossier preparation; identify potential gaps and risks, collaborating with stakeholders to address them.
- Draft and compile CMC sections for regulatory submissions.
- Create and maintain project timelines and plans for CMC submissions.
- Ensure all CMC documentation is accurately stored within the company database.
- Provide expert guidance on ICH, FDA, and EU CMC regulations.
- Foster strong relationships with internal teams, contract manufacturing organizations, and other key partners to align regulatory CMC strategies and achieve regulatory objectives.
- Share expertise and insights with team members.
- Collaborate with external service providers engaged in project support, as necessary.
Required Skills & Qualifications
- Proven experience in CMC Regulatory Affairs.
- Strong background in the pharmaceutical sector.
- Familiarity with topical and/or systemic medications, including Biologics and Small Molecules.
Benefits
- A commitment to diversity and inclusion, believing that varied perspectives lead to improved outcomes.
- A competitive salary package, including bonuses and comprehensive benefits.
- A flexible hybrid work environment.
- Opportunities for personalized career development through feedback loops.
- A chance to be part of a growing organization that empowers employees from day one, encouraging ownership and accountability.
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