东莞招聘

Job Description:
Help to establish high quality and robust CMC regulatory strategies and documents to
support business needs in development.
- Help to establish regulatory CMC strategy for CTA filings in China.
For global projects, support preparation of necessary submission documents for CTAs in
collaboration with global RegCMC.
Investigator’s Brochure, China Addendum, Annual Reports, Application Form
For local projects, in addition, prepare quality part of CTA in collaboration with global
RegCMC.
- Help to establish regulatory CMC strategy for NDA filings in China.
For global projects, support preparation of necessary submission documents for NDAs in
collaboration with global RegCMC.
China specific summaries and summary of changes documents, Application Form
For local projects, in addition, prepare Module 3 documentation in collaboration with
global RegCMC.
2. Help to establish high quality and robust CMC regulatory strategies and documents to
support TechOps and other Novartis division for global marketed products.
Support regulatory evaluation of change requests generated at foreign or domestic manufacture
sites etc. via AWQA and DRAGON based on Chinese guidelines and notifications.
Support preparation of necessary submission documents in collaboration with global
RegCMC.
China specific summaries and summary of changes documents, Application Form.
3. For local marketed products provide high quality and robust CMC regulatory strategies
and documents.
4. Support preparation of answers to questions from Chinese Regulatory Bodies after CTA,
NDA or Post Approval filing in China, and get approval according to the agreed timelines.
If necessary, communicate or negotiate with Chinese Regulatory Bodies to assure timely
approval.
5. Maintain the CMC attributes in DRAGON Country Folder to indicate China status on
Marketed Products precisely.
6. Maintain latest CMC regulatory intelligence in China (e.g. comment on draft Guidelines)
to provide guidance on policies and strategies to global RegCMC and other members appropriately.
Ensure regulatory compliance for all RegCMC deliverables, ensure sharing of
Lessons Learned.
7. Influence and drive regulatory CMC representation in China through participation in industry
groups such as RDPAC.
8. Support divestment and pruning activities and third party customers for Marketed Products
in line with TechOps strategic objectives.
9. Establish and maintain contact with DRA China for all communication on development
and marketed products in China. Establish and maintain sound working relationships with
partners and customers.
10. In partnership with Global RegCMC, initiate and lead Health Authority interactions and
negotiations as appropriate; setting objectives, preparing briefing books, coordinating and
planning rehearsals and risk mitigation plans.


Requirements:
1. 3-5 years in regulatory preferred, and/or experience in
drug/biopharmaceuticals
2. Working knowledge/experience in regulatory submission and approval
processes for new chemical entities (NCE) and product life
cycle management and proven practical knowledge of and ability to
deal with complex CMC regulatory issues and requirements.
3. Proven track record of successfully working in interdisciplinary teams
and planning, coordinating and leading activities simultaneously on
multiple projects.
4. Regularly demonstrated active contributions to line functions or project
teams, as well as ability to contribute to matrix teams with the
necessary strategic thinking.
5. Demonstrated ability for strategic thinking, maintaining awareness of
business impact.
6. Demonstrated ability for risk assessment and mitigation.
7. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
8. Effective planning, organizational and interpersonal skills.
9. Excellent written/spoken communication, negotiation skills and prob-lem solving skills.
10. Computer literacy.
11. Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
12. Fluent English required (oral and written). Fluent in (local) language desired.

www.randstad.cn