Description Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have
Job ResponsibilitiesGeneral Position Summary
The Chemistry Manufacturing Controls Manager will support the execution of global regulatory CMC strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for a small molecule. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.
Key Duties & Responsibilities
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Contributes to the development of global regulatory CMC strategies for commercial products
- Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
- Provides regulatory CMC guidance to cross-functional teams and key stakeholders
- Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Required Education Level & Experience
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, Health Canada, LATAM, Middle East, and ICH) guidelines
- Experience in the preparation, including writing, of CMC submissions
- Strategic thinking and strong problem solving skills
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Capable of strategic thinking with ability to resolve complex and ambiguous situations
- Sound knowledge of cGMP, FDA, EMA, ICH
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
Summary CMC expertise in small molecule experience with support to Regulatory team with Global expansion on multiple markets. Veeva RIM authoring is required.
