宜兴招聘

POSITION RESPONSIBILITIES ：

? Possess a high level of understanding of the technical/regulatory aspects and product characteristics that impact CMC regulatory strategy of assigned products
? Prepares / Authors accurate and complete CMC content to support:
o Introduction of a new commercial product, including new market introductions for existing products
o Post-approval changes
o License maintenance (ex. Renewals, annual reports, gap closures)
? Ensures that submission related deliverables are provided in accordance with project timelines.
? Participates in the review and approval of newly authored submission content
? Performs functions within the RCCM (Regulatory Conformance Change Manager) process for changes impacting the specific global portfolio of products under his/her responsibility.
? Assists team or develops and communicates global/regional regulatory strategies (product & project-level) that identify regulatory risks & mitigation strategies and align with development and/or commercial plans
o Balancing regulatory requirements, constraints and risk posture with WSR, PGS, & Consumer Business goals
o Leverage diverse GCMC expertise and experience to share and incorporate learning’s into future CMC strategies & submissions
o Develop robust global CMC strategies and regulatory submission plans that provide fit for purpose regulatory submissions that will deliver market approvals
o 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
o Use in-depth knowledge of regional/country-specific pre- and post-approval CMC regulations to identify, interpret and apply local CMC requirements, in assigned region
o identify country-specific/regional CMC requirements and opportunities to “bundle” changes to reduce PCO submission volume
o Identify, assess impact & proactively communicate changes to local CMC regulations
o Ensure local submission plans and forecasts meet GCMC, WSR, & PGS requirements
? Interacts with PGS and the Regional Regulatory Hubs/PCOs/WRS/WSRO to ensure effective communication and management of regulatory information and documentation for regulatory conformance and Consumer product life cycle management.
? Identifies and escalates regulatory conformance issues to the appropriate leadership
? Provides regulatory support and assistance to technical groups within the region or market.
? Provides assistance to special projects requiring CMC input.
? Drives and leads discussions related to queries from Health Authorities, ensuring completeness of responses within requested timelines, and compliance of additional CMC information requests.
? Where necessary, provides assistance to internal compliance audits and assists in developing appropriate responses and action plans to address audit observations.
? Fosters a culture of strong performance, assuring that objectives and team goals are developed and measured in alignment with the mission and purpose of the overall organization, and with Pfizer’s core values.
o Leads and participates in the recruitment, selection, promotion, termination and performance management of personnel and contract staff.
o Leads and provides direct input into the following activities:
o Coaching of direct reports
o Development and oversight of training curricula and records
o Individual development plans
o Performance reviews
o Succession planning
o Ensures training on and adherence to the appropriate SOPs, global business practices, policies and job aids, as consistent with business roles.
? 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.

EDUCATION AND EXPERIENCE ：


? Advanced degree (MS, PhD, Pharm. D.) with a minimum of 4 years of relevant experience, or Bachelors degree with a minimum of 6-8 years of relevant experience is required.
? Prior experience managing teams is preferred
? Managing cross-border relationships highly desired
? Prior experience managing projects is required
? Minimum of 4 years of relevant hands-on CMC experience (ex. authoring for initial or post-approval variations for marketed products) is mandatory
? Comprehensive understanding of CTD format and content is madatory
? Global regulatory experience with different Consumer submission types (drug, OTC, food, cosmetic, etc.) is highly preferred

TECHNICAL SKILLS REQUIREMENTS：

? Experience working in the Pharmaceutical manufacturing industry (preferably QA, Technical Services, Operations, Manufacturing or R&D), knowledge of pharmaceutical development processes and cGMPs is required.
? Excellent English writing and oral presentation skills is mandatory.
? Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.

In 1992, Linktop Group was originally founded in Sydney, Australia. After years of elaborate operation and steady development, Linktop has to date expanded into an international group of companies with subsidiaries and representatives in Australia, New Zealand, Singapore, Canada and China etc.

In 1995, Linktop Consulting started executive searching business. With experienced professional experts in HR fields, Linktop remains committing to provide the highest possible standards of professional supports and solution-oriented service to its valued clients in all kinds of industries.