- Serving as CMC representative on a core project(s), managing project activities, assessing regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
- Serving as a technical and scientific resource and providing guidance for the completion of difficult and complex projects.
- Prioritizing & independently completing assigned workload appropriately with minimal supervision.
- Authoring and/or coordinating CMC activities for new registrations, post-approval changes, renewals, annual reports, and line extensions to meet filing requirements. Coordinating & contributing to responses to Agency queries and performing a quality review of regulatory CMC submissions.
- Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing the experience with colleagues and help peer review the variations as required.
- Emerging awareness of new scientific or manufacturing technology.
- Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
- Possesses a sound understanding of business expectations across divisions
- Experience engaging in the external regulatory & pharmaceutical environment is preferred.
- Updates interpret and apply global & regional CMC guidelines. Ability to contribute to global regulatory strategies by proactively discussing with partners.
- An understanding of regulatory requirements & expectations, criteria for submission & approval globally & experience of interactions with regulatory authorities for projects.
Qualification & Experience:
- Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
- A minimum of 5+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
- Advanced skills in written & oral communications are mandatory.
- Bachelor’s / Master’s degree in pharmaceutical sciences &/or technical discipline with 6-10 years of relevant experience in the pharmaceutical industry and at least 5+ years of pharmaceutical regulatory experience.