(Senior) CMC Manager--某500强欧美制药公司

Core responsibilities include but are not limited to:
1、 Possess a high level of understanding of the technical/regulatory aspects and product characteristics that impact CMC regulatory strategy of assigned products
2、Ensures CMC contents are accurately and completely prepared/authored to support:
1) Introduction of a new commercial product, including new market introductions for existing products
2)Post-approval changes
3) License maintenance (ex. Renewals, annual reports, gap closures)
? Ensures that submission related deliverables are provided in accordance with project timelines.
3、 Participates in the review and approval of newly authored submission content
4、Performs functions within the PDM (Product Dossier Manager) system for changes impacting the specific global portfolio of products under his/her responsibility.
5、Develops and communicates regulatory strategies (product & project-level) that identify regulatory risks & mitigation strategies and align with development and/or commercial plans
1)Balancing regulatory requirements, constraints and risk posture with WSR, PGS, & Consumer Business goals
2) Leverage diverse GCMC expertise and experience (regionally and globally) to share and incorporate learnings into future CMC strategies & submissions
3)Develop robust CMC/Regulatory strategies and submission plans that provide fit for purpose regulatory submissions that will deliver market approvals
4)Communicate CMC strategies, regulatory risks and mitigation plans to PCOs in alignment with GCMC “One Voice” . Influence PCO/HA to adopt innovative CMC strategies, when needed
5) Use in-depth knowledge of country-specific pre- and post-approval CMC regulations to identify, interpret and apply local CMC requirements, in assigned region
6) identify country-specific/regional CMC requirements and opportunities to “bundle” changes to reduce PCO submission volume
7)Identify, assess impact & proactively communicate changes to local regulations
8) Ensure local submission plans and forecasts meet GCMC, WSR, & PGS objectives and requirements
6、Interacts with PGS, WSR, WSRO and Commercial to ensure effective communication and management of regulatory information and documentation for regulatory conformance and Consumer product life cycle management.
7、Identifies and escalates regulatory conformance issues to the appropriate Leadership
8、 Provides regulatory support and assistance to technical groups within the region or market.
9、Provides assistance to special projects requiring CMC Regulatory input, including due diligence activities in business development opportunities.
10、Drives and leads discussions related to queries from Health Authorities, ensuring completeness of responses within requested timelines, and compliance of additional CMC information requests.
11、 Where necessary, provides assistance to internal compliance audits and assists in developing appropriate responses and action plans to address audit observations.
12、Fosters a culture of strong performance, assuring team objectives are met and in alignment with business goals.
13、 Participates in Operational Excellence initiatives to identify and implement continous improvement strategies; tracks and reports progress. Assists in the determination and sharing of best practices across the organization.