Responsible to communicate new regulatory guidelines. 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
Accountable 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
Analyze CMC queries from regulatory agencies to look for trending deficiency 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
A good understanding of CMC requirements for clinical trial applications and marketing applications for small molecule
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
Ability to quickly analyze RCMC issues to troubleshoot for resolution for business continuity
Requirements:
Experience in development of Regulatory CMC strategy in support of submissions of clinical trial applications and marketing applications
A 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
Ability to work under pressure to meet short timelines
Ability to work with shifting priorities to meet project deliverables
Good verbal and written communication skills
Strong interpersonal and collaboration skills
Self-motivated professional
Bachelor's degree in chemistry, pharmacy, biology or scientific discipline
Minimum three years experience in the pharmaceutical industry with at least one year in Regulatory CMC development projects
Knowledge of Regulatory CMC requirements for clinical trial applications and marketing applications
Expertise in quality guidelines of ICH, FDA and EMA
A good understanding of the drug development process and pharmaceutical development
Working knowledge of regulatory CMC dossiers for clinical trial applications and marketing applications
Proficient in MS Word, Excel, PowerPoint and MS Project
Effective communication skills
Strong interpersonal skills to be effective in the global team environment
Fluent with the English language. Knowledge of French and/or other EU languages is desirable
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