What are the responsibilities and job description for the CMC Regulatory Affairs Program Manager position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards are properly and timely implemented.
- Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects.
- Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application.
- Review CMC section of submission dossiers for clinical trial application (IMPD / IND) and marketing authorization application (NDA / MAA) for development compounds.
- Support response to CMC queries from worldwide Health Authorities, including acquiring the requested information, creating / updating response documents, coordinating review and finalizing the response.
- Review CMC supporting documents (GMP certificates, Manufacturing / Import Authorization, CoA, QP declarations, MBR) and request these documents from the appropriate associates.
- ccountable to manage the database of GMP certificates & Manufacturing / Import Authorization in Veeva Vault to ensure the documents are up to date for the covered manufacturing sites in the database.
- nalyze CMC queries from regulatory agencies to look for trending deficiencies for improvement of CMC section to support clinical studies and marketing applications.
- Consult with SMD management and RA CMC managers for issues. Drive to ensure timely and appropriate resolution of the issues.
- Experience with the dynamic regulatory landscape, especially in CMC and quality aspects.
- Expertise in ICH, EMA and FDA guidelines.
- Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD / IND) and marketing authorization application (NDA / MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
- good understanding of CMC requirements for clinical trial applications and marketing applications for small molecules.
- Managing expectations on deliverables to meet tight timelines. Handling timeline pressure.
- Cultivating business relationships with GRA, CMC teams, RegOps, CDDC, GRA regions and local affiliates.
- bility to quickly analyze RCMC issues to troubleshoot for resolution for business continuity.
- Experience in development of Regulatory CMC strategy in support of submissions of clinical trial applications and marketing applications.
- good understanding of Regulatory CMC requirements for clinical trial applications and marketing applications.
- Knowledge of worldwide CMC requirements including US, EU, China, Japan, APAC, LATAM and EMEA.
- Expertise in quality guidelines of ICH, FDA and EMA.
- Demonstrated ability to multi-task and to work in a fast-paced global environment.
- bility to work under pressure to meet short timelines.
- bility to work with shifting priorities to meet project deliverables.
- Good verbal and written communication skills.
- Strong interpersonal and collaboration skills.
- Self-motivated professional.
Requirements :
